BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

    MDR report key: 3153147 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05833
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. NO ABNORMAL SHAPE IS NOTED ANYWHERE IN THE LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO ATTEMPTED IMPLANT OF THE RIGHT VENTRICULAR (RV) LEAD, THE RV LEAD WAS NOTED TO HAVE IRREGULAR SHAPED FORMATIONS ON THE LEAD BODY. IT WAS ALSO REPORTED THAT THE IRREGULAR SHAPED FORMATIONS WERE NOTED WITH NEWLY REQUESTED RV LEADS. THEREFORE ONE OF THE ALREADY UNPACKED RV LEADS WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO ATTEMPTED IMPLANT OF THE RIGHT VENTRICULAR (RV) LEAD, THE RV LEAD WAS NOTED TO HAVE IRREGULAR SHAPED FORMATIONS ON THE LEAD BODY. IT WAS ALSO REPORTED THAT THE IRREGULAR SHAPED FORMATIONS WERE NOTED WITH NEWLY REQUESTED RV LEADS. THE LEADS WERE OPENED AND NOT USED. THEREFORE ONE OF THE ALREADY UNPACKED RV LEADS WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256105 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR