BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPICARDIAL PATCH

    MDR report key: 1991411 · Received February 15, 2011

    Report

    Report Number
    2182208-2011-00147
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P900061/S2
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    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 THE LEAD IMPEDANCE TRENDS WERE HIGH FOR THE LAST 2 MONTHS AND THAT THE DEVICE WAS ALERTING THE PATIENT OF THE CONDITION. WHEN THE DEVICE WAS CHECKED, THE IMPEDANCE TRENDS WERE PREVIOUSLY HIGH, BUT WERE OK AT THE TIME OF THE DEVICE CHECK. ADDITIONALLY, THE OPTIVOL FLUID INDEX WAS HIGH OVER THE SAME TIME PERIOD. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEFIBRILLATION PATCH WAS NOTED TO HAVE HIGH IMPEDANCE AND THE PATIENT ALERT SOUNDED. THERE WAS ALSO AN INSULATION BREACH THAT WAS REPAIRED. 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
    1 EPICARDIAL PATCH IMPLANTABLE TACHY LEAD LWS MEDTRONIC, INC. 6721S ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization| O| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4968 IMPLANTABLE PACING LEAD X2| 6949 IMPLANTABLE TACHY LEAD| 6949 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4968 X2 IMPLANTABLE PACING LEADS