BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1231035 · Received October 30, 2008

    Report

    Report Number
    3004209178-2008-07046
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 2, 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
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO REPROGRAM THE IMPLANTABLE NEUROSTIMULATOR AFTER OVERDISCHARGE, AN ISSUE WITH LEAD PLACEMENT WAS IDENTIFIED. RADIOGRAPHIC IMAGING CONFIRMED THAT ONE LEAD WAS IMPLANTED OR HAD MIGRATED ANTERIORLY. THE OTHER LEAD WAS POSITIONED LATERALLY AGAINST THE GUTTER OF THE EPIDURAL SPACE. REPROGRAMMING WAS UNSUCCESSFUL DUE TO LEAD PLACEMENT. THE PT WAS CONSIDERING REVISIONS SURGERY. NO SPECIFIC PT SYMPTOMS WERE REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SUBMITTED IF ADDITIONAL INFO 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 76 YR LEAD: MODEL 3778| IMPLANTED:| LEAD: MODEL 3778| EXPLANTED:| EXPLANTED:| RECHARGER: MODEL 37752| IMPLANTED:| IMPLANTED:| EXPLANTED: