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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0023-2018

Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models 6660, 6661, 6662, 6663

Publicado el 25 de octubre de 2017 · Inicio del retiro: 12 de septiembre de 2017

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

Analysis of the difference between the actual device longevity and the battery indicator status provided by the Clinician Programmer (CP) or Patient Controller (PC) has revealed errors in the CP or PC longevity estimations that can overestimate or under estimate the battery indicator status in certain situations.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
St. Jude Medical, Inc.
Distribuidor
Worldwide Distribution - US (nationwide) (foreign consignee list will be provide by the firm at a later time)
Lote
Serials implanted prior to September 12, 2017 are considered part of this advisory; Serial Numbers - AAD193.1 AAD194.1 AAD213.1 AAD255.1 AAD257.1 AAD261.1 AAD276.1 AAD279.1 AAD281.1 AAD298.1 AAD299.1 AAD302.1 AAD309.1 AAD328.1 AAD372.1 AAD376.1 AAD380.1 AAN940.1 AAN946.1 AAN951.1 AAN977.1 AAN997.1 AAP006.1 AAP007.1 AAP030.1 AAP035.1 AAP108.1 AAP132.1 AAP140.1 AAP149.1 AAP193.1 AAP217.1 AAP266.1 AAP273.1 AAP279.1 AAP293.1 AAP314.1 AAP328.1 AAP333.1 AAP362.1 AAP363.1 AAP375.1 AAP376.1 AAP385.1 AAP387.1 AAP409.1 AAP410.1 AAT509.1 AAT540.1 AAT571.1 AAT572.1 AAT577.1 AAT579.1 AAT582.1 AAT626.1 AAT634.1 AAT652.1 AAT657.1 AAT660.1 AAT722.1 AAT754.1 AAT772.1 AAT774.1 AAT776.1 AAT783.1 AAT792.1 AAT795.1 AAT797.1 AAT804.1 AAT805.1 AAT830.1 AAT841.1 AAT845.1 AAT849.1 AAT870.1 AAT873.1 AAT885.1 AAT890.1 AAT891.1 AAT899.1 AAT902.1 AAT910.1 AAT976.1 AAT987.1 AAT989.1 AAT990.1 AAT994.1 AAU003.1 AAU009.1 AAU022.1 AAU029.1 AAU031.1 AAU046.1 AAU047.1 AAU056.1 AAU068.1 AAU071.1 AAU084.1 AAU094.1 AAU095.1 AAU096.1 AAU148.1 ABA946.1 ABA964.1 ABA995.1 ABB011.1 ABB022.1 ABB051.1 ABB128.1 ABJ141.1 ABJ142.1 ABJ148.1 ABJ155.1 ABJ156.1 ABJ165.1 ABJ175.1 ABJ177.1 ABJ186.1 ABJ196.1 ABJ197.1 ABJ234.1 ABJ242.1 ABJ243.1 ABJ255.1 ABJ282.1 ABJ284.1 ABJ285.1 ABJ295.1 ABJ311.1 ABJ313.1 ABJ315.1 ABJ321.1 ABJ328.1 ABJ349.1 ABJ386.1 ABJ388.1 ABJ390.1 ABJ392.1 ABJ411.1 ABJ444.1 ABJ445.1 ABJ448.1 ABJ449.1 ABJ458.1 ABJ472.1 ABJ485.1 ABJ501.1 ABJ503.1 ABJ504.1 ABJ505.1 ABJ506.1 ABJ526.1 ABJ556.1 ABJ614.1 ABM287.1 ABM308.1 ABM310.1 ABM312.1 ABM313.1 ABM329.1 ABM334.1 ABM381.1 ABM408.1 ABM459.1 ABM471.1 ABM472.1 ABM540.1 ABM541.1 ABM581.1 ABM589.1 ABM592.1 ABM593.1 ABM620.1 ABM630.1 ABM651.1 ABT714.1 ABT728.1 ABT739.1 ABT740.1 ABT745.1 ABT785.1 ABT798.1 ABT800.1 ABT811.1 ABT829.1 ABT832.1 ABT839.1 ABT841.1 ABT844.1 ABT883.1 ABT892.1 ABT900.1 ABT948.1 ABT956.1 ABT967.1 ABT975.1 ABT981.1 ABT984.1 ABT990.1 ABT991.1 ABU014.1 ABU018.1 ABU024.1 ABU036.1 ABU058.1 ABU061.1 ABU079.1 ABU099.1 ABU107.1 ABU119.1 ABU146.1 ABU164.1 ABU183.1 ACD615.1 ACD617.1 ACD652.1 ACD655.1 ACD656.1 ACD682.1 ACD686.1 ACD721.1 ACD768.1 ACD772.1 ACD773.1 ACD797.1 ACD800.1 ACD802.1 ACD812.1 ACD849.1 ACE661.1 ACE669.1 ACE689.1 ACE699.1 ACE740.1 ACE771.1 ACE772.1 ACE780.1 ACE786.1 ACE838.1 ACE843.1 ACE860.1 ACE868.1 ACE875.1 ACE877.1 ACE892.1 ACE900.1 ACE912.1 ACE917.1 ACE922.1 ACE936.1 ACE939.1 ACE942.1 ACE947.1 ACE994.1 ACF006.1 ACF039.1 ACF048.1 ACF065.1 ACK135.1 ACK136.1 ACK140.1 ACK145.1 ACK159.1 ACK161.1 ACK165.1 ACK200.1 ACK224.1 ACK228.1 ACK231.1 ACK241.1 ACK253.1 ACK269.1 ACK286.1 ACK289.1 ACK318.1 ACK325.1 ACK379.1 ACK385.1 ACK424.1 ACK428.1 ACK429.1 ACK431.1 ACK448.1 ACK457.1 ACK500.1 ACK511.1 ACK514.1 ACK525.1 ACK526.1 ACK549.1 ACK554.1 ACK559.1 ACK581.1 ACK583.1 ACK592.1 ACK594.1 ACK602.1 ACK615.1 ACK622.1 ACK629.1 ACK632.1 ACK634.1 ACK637.1 ACK674.1 ACK677.1 ACK699.1 ACK702.1 ACK705.1 ACK706.1 ACK709.1 ACK719.1 ACK739.1 ACK742.1 ACK744.1 ACK752.1 ACK757.1 ACK759.1 ACK760.1 ACK762.1 ACK775.1 ACK776.1 ACK778.1 ACK783.1 ACK784.1 ACK786.1 ACK803.1 ACK805.1 ACK806.1 ACK828.1 ACK837.1 ACK841.1 ACK844.1 ACK846.1 ACK855.1 ACK872.1 ACP669.1 ACP670.1 ACP675.1 ACP676.1 ACP680.1 ACP684.1 ACP685.1 ACP686.1 ACP687.1 ACP690.1 ACP695.1 ACP700.1 ACP737.1 ACP756.1 ACP767.1 ACP769.1 ACP770.1 ACP775.1 ACP777.1 ACP780.1 ACP783.1 ACP797.1 ACP804.1 ACP820.1 ACP824.1 ACP827.1 ACP829.1 ACP833.1 ACP835.1 ACP836.1 ACP862.1 ACP866.1 ACP869.1 ACP872.1 ACP874.1 ACP881.1 ACP883.1 ACP885.1 ACP890.1 ACP893.1 ACP909.1 ACP915.1 ACT538.1 ACT542.1 ACT547.1 ACT548.1 ACT555.1 ACT556.1 ACT558.1 ACT562.1 ACT563.1 ACT565.1 ACT580.1 ACT582.1 ACT589.
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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