Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization th

Is my product affected?

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

• UPC 00643169735705

Check against the official notice below — it lists the full affected range.

What happened

Medtronic is recalling approximately 3,560 units of Percepta Quad CRT-P MRI SureScan implantable pulse generators worldwide, including units distributed in the United States. These devices have a potential safety issue: a timing interaction between two features called EffectivCRT Diagnostic and Ventricular Safety Pacing can cause the device to reset unexpectedly.

The record does not specify what consumers who have received this device should do. Consumers with one of the affected serial numbers listed in the recall should contact their healthcare provider or Medtronic directly for guidance on next steps.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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).

Details from the source

Reason for recall: 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). Distribution: Worldwide Distribution - US Nationwide Quantity: 3560 units Lot/code info: 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 RNV

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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