BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1162670 · Received September 16, 2008

    Report

    Report Number
    3004209178-2008-05803
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    May 1, 2008
    Report Date
    August 20, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUTURE LINE DID NOT HEAL, ERODED AND BECAME INFECTED. THE LEAD HAD MIGRATED OUT OF THE SPINE AND WAS COILED IN THE PATIENT'S SIDE. THE PATIENT HAD BEEN ON ANTIBIOTICS FOR 3 MONTHS AND THE WOUND WAS NOT HEALING. THE PATIENT TURNED OFF STIMULATION AND THE IMPLANT WILL BE REMOVED. DEVICE REGISTRATION SYSTEM INDICATES A NEW NEUROSTIMULATION SYSTEM WAS IMPLANTED IN 2008. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGEABLE LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED| LEAD MODEL 3777 LOT # V070251016 IMPLANTED| EXPLANTED| LEAD MODEL 3777 LOT # V070251015 IMPLANTED