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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2415-2018

Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive bradycardia pacing, sequential biventricular pacing, and atrial tachyarrhythmia therapies. These devices are indicated for heart failure patients who may have atrial arrhythmias or AV block.

Publicado el 18 de julio de 2018 · Inicio del retiro: 21 de junio de 2018

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

Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan due to a timing interaction between the EffectivCRT Diagnostic and the Ventricular Safety Pacing feature (VSP).

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Distribuidor
Worldwide Distribution - US Nationwide
Lote
GTIN/UPN: (a) 00643169735705 Serial Numbers: RNV601570S RNV601571S RNV601972S RNV603768S RNV603769S RNV603802S RNV602113S RNV603803S RNV603804S RNV603805S RNV603806S RNV603807S RNV603809S RNV603813S RNV603815S RNV603821S RNV603822S RNV603830S RNV603831S RNV603850S RNV603877S RNV603879S RNV603458S RNV603260S RNV603476S RNV603477S RNV603209S RNV603032S RNV602351S RNV603137S RNV603231S RNV603232S RNV602932S RNV602933S RNV602934S RNV602950S RNV602952S RNV602953S RNV602956S RNV602958S RNV602960S RNV602966S RNV602974S RNV602975S RNV602977S RNV603843S RNV603845S RNV601392S RNV601414S RNV601558S RNV601561S RNV601562S RNV601563S RNV601564S RNV601565S RNV601566S RNV601567S RNV601568S RNV601569S RNV601572S RNV601573S RNV601574S RNV601575S RNV601591S RNV601592S RNV601594S RNV601595S RNV601596S RNV601597S RNV601598S RNV601599S RNV601600S RNV601603S RNV601617S RNV601618S RNV601619S RNV601620S RNV601621S RNV601673S RNV601817S RNV601934S RNV601935S RNV601936S RNV601937S RNV601938S RNV601940S RNV601941S RNV601942S RNV601949S RNV601983S RNV601984S RNV601985S RNV601986S RNV601987S RNV601988S RNV601989S RNV601990S RNV601992S RNV601993S RNV601994S RNV601996S RNV601997S RNV601998S RNV601999S RNV602000S RNV602119S RNV602305S RNV602383S RNV603345S RNV603365S RNV603369S RNV603693S RNV603703S RNV603704S RNV603705S RNV603706S RNV603707S RNV603737S RNV603982S RNV603983S RNV603984S RNV603985S RNV603986S RNV603987S RNV603988S RNV603989S RNV603990S RNV603991S RNV603992S RNV603993S RNV603994S RNV603995S RNV603996S RNV603997S RNV603998S RNV603999S RNV604000S RNV604001S RNV604003S RNV604004S RNV604005S RNV604006S RNV604007S RNV604008S RNV604009S RNV604010S RNV604011S RNV604012S RNV602341S RNV601850S RNV602343S RNV602345S RNV602353S RNV602355S RNV602359S RNV603005S RNV603011S RNV603018S RNV603024S RNV603029S RNV603031S RNV603033S RNV603034S RNV603039S RNV603041S RNV603042S RNV603273S RNV603275S RNV603276S RNV603348S RNV602749S RNV603195S RNV603218S RNV603221S RNV603222S RNV603224S RNV603225S RNV603226S RNV603481S RNV603482S RNV603511S RNV603512S RNV603516S RNV603517S RNV603518S RNV603520S RNV603521S RNV603523S RNV603524S RNV603526S RNV603538S RNV603540S RNV603560S RNV603574S RNV603582S RNV601835S RNV601842S RNV601871S RNV601833S RNV601845S RNV601851S RNV601852S RNV602346S RNV603036S RNV603474S RNV603475S RNV603501S RNV603844S RNV603846S RNV603847S RNV603848S RNV603849S RNV603851S RNV603852S RNV603853S RNV603854S RNV603855S RNV603856S RNV603857S RNV603858S RNV603859S RNV603860S RNV603862S RNV603863S RNV603864S RNV603865S RNV603866S RNV603867S RNV603868S RNV603869S RNV603870S RNV603871S RNV603872S RNV603873S RNV603874S RNV603875S RNV603876S RNV603878S RNV603880S RNV603881S RNV603883S RNV603884S RNV603886S RNV603887S RNV603889S RNV603890S RNV603891S RNV603892S RNV603893S RNV603896S RNV603897S RNV603898S RNV603899S RNV603900S RNV603901S RNV603903S RNV603904S RNV603905S RNV603906S RNV603907S RNV603908S RNV603909S RNV603910S RNV603911S RNV603912S RNV603913S RNV603914S RNV603915S RNV603916S RNV603917S RNV603918S RNV603919S RNV603920S RNV603922S RNV603923S RNV603924S RNV603925S RNV603926S RNV603927S RNV603928S RNV603929S RNV603930S RNV603931S RNV603932S RNV603934S RNV603935S RNV603938S RNV603939S RNV603940S RNV603943S RNV603945S RNV603946S RNV603947S RNV603948S RNV603949S RNV603952S RNV603954S RNV603955S RNV603956S RNV603957S RNV603958S RNV603959S RNV603960S RNV603961S RNV603962S RNV603963S RNV603964S RNV603965S RNV603966S RNV603967S RNV603968S RNV603969S RNV603970S RNV603971S RNV603972S RNV603974S RNV604002S RNV604013S RNV604014S RNV604015S RNV604016S RNV604017S RNV604018S RNV604019S RNV604020S RNV604021S RNV604022S RNV604023S RNV604024S RNV
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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