BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1163595 · Received September 17, 2008

    Report

    Report Number
    3004209178-2008-05854
    Event Type
    Injury
    Date Received
    September 17, 2008
    Date of Event
    August 18, 2008
    Report Date
    August 19, 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
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE NEUROSTIMULATOR AND LEADS WERE RETURNED FOR ANALYSIS. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT DEVELOPED AN AREA OF REDNESS AROUND THE NEUROSTIMULATOR SITE. THE AREA HAD THE APPEARANCE OF ERYTHEMATOUS. A CONSULTANT WAS CONCERNED THAT AN INFECTION MAY BE PRESENT. THE NEUROSTIMULATOR WAS EXPLANTED. CULTURE SWABS WERE OBTAINED; THE SWABS WERE SENT FOR CULTURE AND SENSITIVITY. IT WAS REPORTED THE END OF THE IMPLANTED SURGICAL LEAD WAS CUT OFF APPROX 5MM FROM THE LEAD SOCKET AND REMAINED IN THE NEUROSTIMULATOR. IT IS UNCLEAR WHETHER THE REST OF THE LEAD WAS EXPLANTED. ADD'L INFO HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED| EXPLANTED| LEAD (X2) MODEL UNK