BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SCV LEAD

    MDR report key: 75721 · Received March 10, 1997

    Report

    Report Number
    75721
    Event Type
    Injury
    Date Received
    March 10, 1997
    Date of Event
    November 4, 1996
    Report Date
    November 8, 1996
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ICD LEAD EROSION WITH PUS-LIKE DRAINAGE NOTED BY PT. OBSERVED LEAD ERODING THROUGH SKIN IN THE CLAVICULAR AREA. CHEST X-RAY SHOWED EVIDENCE OF LEAD FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC SCV LEAD Implant ICD TRANSVENOUS LEAD LWS MEDTRONIC, INC. 6963 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention MEDTRONIC ICD MODEL 7217 IMPLANTED| 12/28/92 AND REPLACED 11/8/96 SECONDARY TO| BATTERY DEPLETION W/MODEL 7221 ICD