BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO

    MDR report key: 2954561 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-02390
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 28, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE PHYSICIAN DECIDED TO CUT THE LOBES OF THE LEAD BECAUSE THE PATIENT WAS THIN AND THE POCKET WAS SMALL. THE PHYSICIAN ACCIDENTLY CUT THE INSULATION LAYER OF THE LEAD. THE PHYSICIAN COMPLAINT THAT THE LEAD'S LOBES ARE TOO BIG AND THE INSULATION LAYER IS TOO THIN. THE LEAD WAS NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57893 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1