BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPICARDIAL PATCH

    MDR report key: 2131971 · Received June 16, 2011

    Report

    Report Number
    2182208-2011-00945
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    April 15, 2010
    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
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 THE RV DEFIB AND SVC IMPEDANCES JUMPED FROM 37 TO GREATER THAN 200 OHMS. IT WAS LATER REPORTED THAT THE HIGH VOLTAGE LEAD HAD HIGH THRESHOLDS AND A POSSIBLE LEAD FRACTURE. THE SVC AND HIGH VOLTAGE LEADS WAS CAPPED. 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. 6721M ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| R 4968 IMPLANTABLE PACING LEAD| C154DWK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5071 IMPLANTABLE PACING LEAD X4| 586638M IMPLANTABLE LEAD ADAPTOR X2