BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 822835 · Received February 27, 2007

    Report

    Report Number
    3004209178-2007-00696
    Event Type
    Injury
    Date Received
    February 27, 2007
    Date of Event
    February 1, 2007
    Report Date
    February 1, 2007
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    p840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY DEVICE ANALYSIS WAS NOT AVAILABLE ON THE DATE OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN FINAL DEVICE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    HCP REPORTED THE PT WAS HOSPITALIZED FOR A STAPH INFECTION APPROX ONE MONTH POST-IMPLANT OF DEVICE SYSTEM. AFTER HOSPITALIZATION, THE STIMULATION COVERAGE WAS INTERMITTENT AND THE PT FELT "SHOCKING SENSATIONS". IMPEDENCES WERE NORMAL. THE DEVICE WAS EXPLANTED AND RETURNED TO THE MFR FOR ANALYSIS. ADDITIONAL INFO HAS BEEN REQUESTED BY MFR FROM THE HEALTH CARE PROFESSIONAL REGARDING THE REPORTED EVENT. A SUPPLEMENTAL MDR F/U REPORT WILL BE SENT TO FDA IF ADDITIONAL INFO IS RECEIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention EXTENSION MODEL 37081 LOT# NJB009499V IMPLANTED| EXPLANTED| EXTENSION MODEL 37081 LOT# NJB009498V IMPLANTED| LEAD MODEL 3778 LOT# V015093 IMPLANTED| EXPLANTED| LEAD MODEL 3778 LOT# V015093 IMPLANTED| EXPLANTED| EXPLANTED