BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1071622 · Received July 9, 2008

    Report

    Report Number
    3004209178-2008-03872
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    December 19, 2007
    Report Date
    June 9, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE PT HAD AN IMPLANTABLE NEUROSTIMULATOR BATTERY REPLACEMENT IN 2007. APPROX 2 WEEKS LATER, THE PT WOKE UP EXPERIENCING INTERMITTENT STIMULATION. GROUP IMPEDANCE WAS NORMAL THE FIRST TIME IT WAS CHECKED; THE SECOND TIME IT WAS > 3600 OHMS. ALL BIPOLAR ELECTRODE COMBINATION IMPEDANCES WERE > 3600 OHMS EXCEPT FOR CONTACT COMBINATION 3-6, WHICH HAD AN IMPEDANCE OF 509 OHMS. THE DEVICE WAS REPROGRAMMED. ANTERO-POSTERIOR CERVICAL, THRORACIC, AND LUMBAR X-RAYS OF THE SPINE TAKEN AT ABOUT 18 DAYS LATER SHOWED THE ELECTRODES WERE PRESENT. THE LEAD IN THE CERVICAL SPINE WAS REPLACED. THE PT EXPERIENCED NO STIMULATION, LACK OF EFFECT AND FELT PRE-EXISTING PAIN. THE HCP REPORTED THE PT OUTCOME AS 'NO INJURY, RECOVERED WITHOUT SEQUELA'.

    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 Required Intervention IMPLANTED| IMPLANTED| IMPLANTED| EXTENSION MODEL 37081 LOT# NJB006618N| EXPLANTED| IMPLANTED| EXPLANTED| EXPLANTED| LEAD MODEL # 377745| IMPLANTED| EXPLANTED| EXTENSION MODEL 37081 LOT# NJB006617N| EXTENSION MODEL 7489 LOT# NHU008804V| EXPLANTED| PROGRAMMER MODEL 37742 LOT# NJD011641N| LEAD MODEL # 377745