Device product

ICD EVERA XT DR GOLD CTD, Model Number DDBB1D4G; Implantable Cardioverter Defibrillators

Z-1706-2023

May 10, 2023

Class I

Product summary

Firm: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Event: Event 92328
Status: Ongoing
Classification: Class I
Quantity: 1 unit
Official record key: device-enforcement:Z-1706-2023

Official wording

Reason: There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.

Code information: GTIN 00643169518216, Lot Serial Numbers: BWB232002H

Distribution pattern: US Nationwide - Worldwide Distribution

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.