BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC III PROTECT

    MDR report key: 3993841 · Received August 8, 2014

    Report

    Report Number
    9614453-2014-01866
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    March 10, 2014
    Report Date
    June 26, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. THIS EVENT OCCURRED OUTSIDE THE U.S. AND PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT PRODUCT: 6947 LEAD, IMPLANT DATE UNKNOWN; 4194 LEAD, IMPLANT DATE UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED DUE TO PREMATURE BATTERY DEPLETION. IT WAS FURTHER REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS EXHIBITING LOW IMPEDANCE AND UNSTABLE SENSING. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469204 INSYNC III PROTECT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND 7285

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Hospitalization| R 4574 LEAD