BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC

    MDR report key: 376113 · Received February 8, 2002

    Report

    Report Number
    MW1024037
    Event Type
    Other
    Date Received
    February 8, 2002
    Date of Event
    December 17, 2001
    Report Date
    January 29, 2002
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADMITTED ELECTIVELY FOR EXTRACTION OF ICD DUE TO MALFUNCTIONING. PT IS PACEMAKER DEPENDENT. INTRA-OP LEFT SUBCLAVIAN VEIN FOUND OCCLUDED. THRU LEFT INTERIOR JUGULAR NEW DE-FIB BI-COIL LEAD TUNNELED TO RIGHT VENTRICLE. POST-OP PT REMAINED IN HOSP DUE TO MODERATE SIZE POCKET HEMATOMA PLUS LEFT UPPER ARM SWELLING. PT DISCHARGED POST-OP DAY 3. LEAD DEVICE TO PATHOLOGY FOR GROSS EXAM.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 4/15/02: THE DEVICE MODEL IS 6936. MFR HAS NO ADD'L INFO ON THE REPORTED EVENT OTHER THAN WHAT IS CONTAINED IN THE FEFERENCED VOLUNTARY MEDWATCH REPORT. THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. WITHOUT THE RETURN AND ANALYSIS OF THE REPORTED DEVICE, NO CONCLUSION CAN BE DRAWN AS TO THE REPORTED EVENT AND DEVICE PERFORMANCE. MFR'S ALERT DATE FOR THIS EVENT IS 2/17/02 THAT REFLECTS THE DATE THEY RECEIVED A VOLUNTARY MEDWATCH REPORT FROM THE USER FACILITY. THE INFO RECEIVED FROM THE VOLUNTARY MEDWATCH REPORT INDICATES THE DEVICE WAS EXPLANTED. THE DEVICE HAS NOT BEEN RETURNED TO MEDTRONIC FOR ANALYSIS. TOTAL IMPLANT DURATION: 75 MOS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ICD LEAD LWS MEDTRONIC, INC. 6936-65 *

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other