BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA DR

    MDR report key: 2954571 · Received February 11, 2013

    Report

    Report Number
    9614453-2013-00472
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    December 27, 2012
    Report Date
    February 26, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE U.S., HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. 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 DEVICE WAS RETURNED AND ANALYZED. THERE WERE NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT, WHEN THE PHYSICIAN ATTACHED THE ATRIAL LEAD TO THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THE PARAMETERS WERE NOT GOOD. THEY CHECKED THE CONNECTION AND THE WHEN THE PHYSICIAN ATTEMPTED TO UNSCREW THE LEAD THE SCREWDRIVER BROKE. ANOTHER SCREWDRIVER WAS ATTEMPTED AND BROKE. A NEW DEVICE WAS IMPLANTED WITH GOOD PARAMETERS AND 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
    59637 PROTECTA DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D364DRM

    Patients

    Seq Age Sex Outcome Treatment
    1