BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPICARDIAL PATCH

    MDR report key: 1992661 · Received February 15, 2011

    Report

    Report Number
    2182208-2011-00204
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    June 8, 2009
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P900061/S2
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY AFTER IMPLANT OF THE TRIPLE-CHAMBER ICD SYSTEM, THE IMPEDANCE OF THE EPICARDIAL PATCH DEFIBRILLATION ELECTRODES HAD DECREASED FROM THE VALUES SEEN AT IMPLANT. IT WAS LATER REPORTED THAT THE IMPEDANCE OF ONE OF THE ELECTRODES, THE ONE PLUGGED INTO THE SUPERIOR VENA CAVA COIL (SVC) PORT, HAD SUDDENLY INCREASED TO A HIGH VALUE. THE ELECTRODES REMAIN 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
    1 EPICARDIAL PATCH IMPLANTABLE TACHY LEAD LWS MEDTRONIC, INC. 6721L ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other 4193 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 6721L IMPLANTABLE TACHY LEAD| 5071X2 IMPLANTABLE PACING LEAD| C154DWK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 586638M IMPLANTABLE LEAD ADAPTOR