BEUDAMED
    FDA Adverse Event Summary report: N

    IS1 BIPOLAR/LV1 BIPOLAR

    MDR report key: 3041023 · Received June 27, 2006

    Report

    Report Number
    2124215-2006-18534
    Date Received
    June 27, 2006
    Date of Event
    March 9, 2008
    Report Date
    June 27, 2006
    Manufacturer
    INNO-MEDICA
    Product Code
    DTD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOCAL GUIDANT SALES REP CONFIRMED THAT THIS LEFT VENTRICULAR EPICARDIAL LEAD AND ADAPTER WOULD NOT BE RETURNED TO GUIDANT FOR ANALYSIS, AS THE LEAD AND ADAPTER WERE DISCARDED. NO ADD'L INFO IS AVAILABLE AT THIS TIME. SHOULD ADD'L INFO BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    EVENT DESCRIPTION: GUIDANT RECEIVED INFO THAT THIS LEFT VENTRICULAR EPICARDIAL LEAD WAS LASER EXTRACTED DUE TO A FRACTURE AT THE INSERTION OF THE LEAD WITH THIS ADAPTER. IT WAS REPORTED THAT THE PT HAD BEEN EXPERIENCING STIMULATION IN THE LEFT PECTORAL AREA. ANOTHER LEFT VENTRICULAR EPICARDIAL LEAD WAS SUCCESSFULLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IS1 BIPOLAR/LV1 BIPOLAR LEAD ADAPTOR DTD INNO-MEDICA 4402

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention (B)(4) LV EPICARDIAL| EXPLANTED:| IMPLANTED: