BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 2120169 · Received June 6, 2011

    Report

    Report Number
    3004209178-2011-04019
    Event Type
    Injury
    Date Received
    June 6, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 6, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER 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 PATIENT EXPERIENCED A FALL AND THEN NOTED HER STIMULATION WAS NOT PROVIDING THE SAME LEVEL OF PAIN RELIEF AND COVERAGE. IMPEDANCE READINGS ON HER LEFT LEAD WERE >3600 OHMS. DURING REVISION SURGERY, THE LEAD WAS RETESTED AND SHOWED IMPEDANCE READINGS OF >10,000 OHMS. TWO LEADS AND THE DEVICE WERE REPLACED. FOLLOWING THE REPLACEMENT, THE PATIENT WAS DOING VERY WELL WITH EXCELLENT COVERAGE TO THE AFFECTED AREA OF PAIN. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention IMPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7495LZ, LOT# NHK009474V| PROGRAMMER: MODEL 37742, LOT# NJD025842N| EXTENSION: MODEL 7495LZ, LOT# NHK009475V| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA022786N| IMPLANTED:| LEAD: MODEL 3778, LOT# V007391| LEAD: MODEL 3778, LOT# V007391| EXPLANTED:| IMPLANTED: