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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1661-2014

Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generator (EPG) Temporary Pacemaker (AAI/VVI). Used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. The device is typically connected to temporary transvenous, epicardial or myocardial pacing leads, in a bipolar configuration, using a patient cable (Medtronic Model 5433A or 5433V) or a surgical cable (Medtronic Model 5832 or 5832S).

Publicado el 4 de junio de 2014 · Inicio del retiro: 29 de abril de 2014

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Events related to a pacing rate outside of the intended setting, including events of sudden increased pacing rate up to the maximum setting of 180 pulses per minute (ppm), have been reported. This is caused by the development of high resistance on internal electrical connector contacts due to oxidation over time.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Medtronic Inc. Cardiac Rhythm Disease Management
Distribuidor
Worldwide Distribution -- USA, including the territories of Guam and Puerto Rico; and, the countries of Albania, Algeria, Australia, Austria, Bahamas, Bangladesh, Belarus, Belgium, Benin, Bolivia, Bosnia And Herzegovina, Brazil, Bulgaria, Burkina Faso, Chile, Colombia, Costa Rica, Cote D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, Georgia, Germany, Greece, Guadeloupe, Honduras, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macau, Malaysia, Malta, Martinique, Mauritius, Mexico, Morocco, Nepal, Netherlands, Netherlands Antilles, New Caledonia, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Saudi Arabia, Senegal, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Yemen.
Lote
serial numbers: PEP001001K, PEP001001P, PEP001002K, PEP001002P, PEP001003K, PEP001003P, PEP001004K, PEP001004P, PEP001005K, PEP001005P, PEP001006K, PEP001006P, PEP001007K, PEP001007P, PEP001008K, PEP001008P, PEP001009K, PEP001009P, PEP001010K, PEP001010P, PEP001011K, PEP001011P, PEP001012K, PEP001012P, PEP001013K, PEP001013P, PEP001014K, PEP001014P, PEP001015K, PEP001015P, PEP001016K, PEP001016P, PEP001017K, PEP001017P, PEP001018K, PEP001018P, PEP001019K, PEP001019P, PEP001020K, PEP001020P, PEP001021K, PEP001021P, PEP001022K, PEP001022P, PEP001023K, PEP001023P, PEP001024K, PEP001024P, PEP001025K, PEP001025P, PEP001026K, PEP001026P, PEP001027K, PEP001027P, PEP001028K, PEP001028P, PEP001029K, PEP001029P, PEP001030K, PEP001030P, PEP001031K, PEP001031P, PEP001032K, PEP001032P, PEP001033K, PEP001033P, PEP001034K, PEP001034P, PEP001035K, PEP001035P, PEP001036K, PEP001036P, PEP001037K, PEP001037P, PEP001038K, PEP001038P, PEP001039K, PEP001039P, PEP001040K, PEP001040P, PEP001041K, PEP001041P, PEP001042K, PEP001042P, PEP001043K, PEP001043P, PEP001044K, PEP001044P, PEP001045K, PEP001045P, PEP001046K, PEP001046P, PEP001047K, PEP001047P, PEP001048K, PEP001048P, PEP001049K, PEP001049P, PEP001050K, PEP001050P, PEP001051K, PEP001051P, PEP001052K, PEP001052P, PEP001053K, PEP001053P, PEP001054K, PEP001054P, PEP001055K, PEP001055P, PEP001056K, PEP001056P, PEP001057K, PEP001057P, PEP001058K, PEP001058P, PEP001059K, PEP001059P, PEP001060K, PEP001060P, PEP001061K, PEP001061P, PEP001062K, PEP001062P, PEP001063K, PEP001063P, PEP001064K, PEP001064P, PEP001065K, PEP001065P, PEP001066K, PEP001066P, PEP001067K, PEP001067P, PEP001068K, PEP001069K, PEP001069P, PEP001070K, PEP001070P, PEP001071K, PEP001071P, PEP001072K, PEP001072P, PEP001073K, PEP001073P, PEP001074K, PEP001074P, PEP001075K, PEP001075P, PEP001076K, PEP001076P, PEP001077K, PEP001077P, PEP001078K, PEP001078P, PEP001079K, PEP001079P, PEP001080K, PEP001080P, PEP001081K, PEP001081P, PEP001082K, PEP001082P, PEP001083K, PEP001083P, PEP001084K, PEP001084P, PEP001085K, PEP001085P, PEP001086K, PEP001086P, PEP001087K, PEP001087P, PEP001088K, PEP001088P, PEP001089K, PEP001089P, PEP001090K, PEP001090P, PEP001091K, PEP001091P, PEP001092K, PEP001092P, PEP001093K, PEP001093P, PEP001094K, PEP001094P, PEP001095K, PEP001095P, PEP001096K, PEP001096P, PEP001097K, PEP001097P, PEP001098K, PEP001098P, PEP001099K, PEP001099P, PEP001100K, PEP001100P, PEP001101K, PEP001101P, PEP001102K, PEP001102P, PEP001103K, PEP001103P, PEP001104K, PEP001104P, PEP001105K, PEP001105P, PEP001106K, PEP001106P, PEP001107K, PEP001107P, PEP001108K, PEP001108P, PEP001109K, PEP001109P, PEP001110K, PEP001110P, PEP001111K, PEP001111P, PEP001112K, PEP001112P, PEP001113K, PEP001113P, PEP001114K, PEP001115K, PEP001115P, PEP001116K, PEP001116P, PEP001117K, PEP001117P, PEP001118K, PEP001118P, PEP001119K, PEP001119P, PEP001120K, PEP001120P, PEP001121K, PEP001121P, PEP001122K, PEP001122P, PEP001123K, PEP001123P, PEP001124K, PEP001124P, PEP001125K, PEP001125P, PEP001126K, PEP001126P, PEP001127K, PEP001127P, PEP001128K, PEP001128P, PEP001129K, PEP001129P, PEP001130K, PEP001130P, PEP001131K, PEP001131P, PEP001132K, PEP001132P, PEP001133K, PEP001133P, PEP001134K, PEP001134P, PEP001135K, PEP001135P, PEP001136K, PEP001136P, PEP001137K, PEP001137P, PEP001138K, PEP001138P, PEP001139K, PEP001139P, PEP001140K, PEP001140P, PEP001141K, PEP001141P, PEP001142K, PEP001142P, PEP001143K, PEP001143P, PEP001144K, PEP001144P, PEP001145K, PEP001145P, PEP001146K, PEP001146P, PEP001147K, PEP001147P, PEP001148K, PEP001148P, PEP001149K, PEP001149P, PEP001150K, PEP001150P, PEP001151K, PEP001151P, PEP001152K, PEP001152P, PEP001153K, PEP001153P, PEP001154K, PEP001154P, PEP001155K, PEP001155P, PEP001156K, PEP001156P, PEP001157K, PEP001157P, PEP001158K, PEP001158P, PEP001159K, PEP001159P, PEP001160K, PEP001160P, PEP001161K, PEP001161P, PEP001162K, PEP001162P, PEP001163K, PEP001163P, PEP001164K, PEP001164P, PEP001165K, PEP001165P, PEP001166K, PEP001166P, PEP001167K, PEP001167P,
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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