BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 819507 · Received February 19, 2007

    Report

    Report Number
    3004209178-2007-00596
    Event Type
    Injury
    Date Received
    February 19, 2007
    Report Date
    January 31, 2007
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MFR REP REPORTED DEVICE SYSTEM WAS REMOVED DUE TO INFECTION. ADD'L INFO HAS BEEN REQUESTED BY MEDTRONIC FROM THE HEALTH CARE PROFESSIONAL REGARDING THE REPORTED EVENT. A SUPPLEMENTAL MDR F/U REPORT WILL BE SENT TO FDA IF ADD'L INFO IS REC'D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGABLE NEUROSTIMULATOR LGW LGW MDT PUERTO RICO OPERATIONS CO, JUNCOS 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention LEAD MODEL 3778, LOT # V017382, IMPLANTED| LEAD MODEL 3778, LOT # V012472, IMPLANTED| EXPLANTED| EXPLANTED