BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N/A

    MDR report key: 2964966 · Received February 15, 2013

    Report

    Report Number
    9614453-2013-00404
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    February 20, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. A HIGH CURRENT DRAIN CONDITION WAS FOUND DURING DEVICE ANALYSIS. ELECTRICAL ANALYSIS REVEALED THE CAUSE OF THE HIGH CURRENT DRAIN WAS CURRENT LEAKAGE IN THE BATTERY FILTER CAPACITORS.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. PRODUCT EVENT SUMMARY: PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. THE TIME OF RECOMMENDED REPLACEMENT TIME (RRT) WAS (B)(6) 2012 AT LESS OR EQUAL TO 2.62 VOLT. THE WEEKLY BATTERY VOLTAGE TREND DATA SHOWS MINIMUM BATTERY OF 2.64 TO 2.62 VOLTS BETWEEN (B)(6) 2012. THERE WAS ALSO A LOW BATTERY VOLTAGE ALERT ON (B)(6) 2012.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HEARD A DEVICE ALERT. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)  WAS FOUND TO HAVE DEPLETED IN BATTERY VOLTAGE RAPIDLY WITHIN SIX MONTHS. THE ICD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68269 N/A DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND C174AWK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R