BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1180192 · Received September 29, 2008

    Report

    Report Number
    3004209178-2008-06182
    Event Type
    Injury
    Date Received
    September 29, 2008
    Date of Event
    August 28, 2008
    Report Date
    August 28, 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
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MFR FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE MFR'S REP WAS UNABLE TO OBTAIN TELEMETRY OR RECHARGE THE DEVICE, IT WAS SUSPECTED TO HAVE FLIPPED IN THE POCKET. THE PT UNDERWENT REVISION SURGERY TO REPOSITION THE DEVICE. AFTER THE REVISION, MULTIPLE ATTEMPTS WERE MADE TO RECHARGE THE DEVICE WITHOUT SUCCESS, THE PT HAD THE DEVICE REPLACED. THE PT RECOVERED WITHOUT SEQUELA. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention UNKNOWN CONVERSION TYPE MODEL LEADN| PROGRAMMER MODEL PROGRAMMER LOT# UNK| IMPLANTED| LOT # UNKNOWN| EXPLANTED