BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARQUIS DR

    MDR report key: 1992010 · Received February 15, 2011

    Report

    Report Number
    6000094-2011-00299
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    December 20, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S23
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) DURING A PROGRAMMED CHARGE AT IMPLANT, THE CHARGE FET Q1 DEVELOPED A LOW IMPEDANCE PATH FROM DRAIN TO SOURCE. THIS RESULTED IN THE SAME LOW IMPEDANCE DIRECTLY ACROSS THE BATTERY CAUSING IT TO RAPIDLY DEPLETE. THE END RESULT WAS THAT THE DEVICE LOST TELEMETRY AND FUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT IMPLANT THE DEVICE COULD NOT FINISH THE LOAD AFTER MORE THAN 54 SECONDS. AN EXTERNAL RESCUE SHOCK WAS ADMINISTERED TO THE PATIENT. THE DEVICE WAS VERY HOT. THE PHYSICIAN REPLACED THE DEVICE WITH A NEW ICD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ASKU

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARQUIS DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. 7274 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R