BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1132601 · Received August 22, 2008

    Report

    Report Number
    3004209178-2008-05151
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    January 1, 2008
    Report Date
    July 23, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS OF THE NEUROSTIMULATOR REVEALED NO ANOMALIES; NORMAL DEVICE FUNCTION. THE DEVICE PASSED THE AUTOMATED TEST CONSOLE. FOREIGN MATERIAL WAS FOUND IN CONNECTOR PORT(S). THE INSULATION COATING SCRATCHED. THE TITANIUM CAN WAS SCRATCHED. THERE WAS GOOD STABLE OUTPUT OBSERVED ON EACH ELECTRODE PAIR. A POR OCCURRED. THE DEVICE WAS RECHARGED USING PHYSICIAN MODE RECHARGE. DEVICE ANALYSIS OF THE LEADS REVEALED NO SIGNIFICANT ANOMALIES. THE CONTINUITY WAS ACCEPTABLE. THE PROXIMAL AND DISTAL ENDS WERE INTACT AND UNDAMAGED. THE OUTER INSULATION WAS CUT/REACHED. SUSPECTED BODY FLUIDS WERE OBSERVED IN THE LEAD WITH NO IMPACT IN LEAD PERFORMANCE. THERE WAS SUSPECTED TOOL MARKS IN THE OUTER INSULATION. DEVICE ANALYSIS OF THE EXTENSION REVEALED NO SIGNIFICANT ANOMALIES. ALL/MULTIPLE CONDUCTORS/WIRES WERE CUT. THE EXTENSION WAS CUT (SUSPECT EXPLANT DAMAGE). THE PRODUCT WAS SEGMENTED. THE DISTAL END OF THE EXTENSION WAS NOT RETURNED. THE PROXIMAL END OF THE EXTENSION WAS INTACT AND UNDAMAGED. DEVICE ANALYSIS OF ADDITIONAL DEVICES REVEALED NO SIGNIFICANT ANOMALIES. ALL/MULTIPLE CONDUCTORS/WIRES WERE CUT ON THE EXTENSION. THE DISTAL AND PROXIMAL ENDS WERE INTACT AND UNDAMAGED. THE PRODUCT WAS SEGMENTED. THE EXTENSION WAS CUT THROUGH (SUSPECTED EXPLANT DAMAGE) AND THE BODY/INSULATION WAS CUT THROUGH ALL/MULTIPLE CONDUCTORS/WIRES CUT ON THE LEADS. THE DISTAL AND PROXIMAL ENDS WERE INTACT AND UNDAMAGED. THE PRODUCT WAS SEGMENTED. THE PROXIMAL END OF THE LEAD WAS NOT RETURNED. THE LEAD BODY/INSULATION WAS CUT THROUGH (SUSPECT EXPLANT DAMAGE). THE OUTER INSULATION WAS WRINKLED. SUSPECTED BODY FLUIDS WERE OBSERVED IN THE LEAD WITH NO IMPACT ON LEAD PERFORMANCE. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT NEVER HAD THERAPEUTIC EFFECT. THE PT SYMPTOMS INCLUDED A BURNING SENSATION, NAUSEA AND SWELLING AT THE NEUROSTIMULATOR, EXTENSION AND LEAD SITES. THE PT WAS AT HOME IN FAIR CONDITION AT THE TIME OF THIS REPORT. IT WAS REPORTED THE PT WAS UNABLE TO GET STIMULATION IN THE BACK AREA. THE PT EXPERIENCED INCREASING BACK PAIN. THE PT WAS UNRESPONSIVE TO STIMULATION DESPITE NUMEROUS REPROGRAMMING SESSIONS. MULTIPLE OFFICE VISITS AND MEDICATIONS WERE REPORTED. NOTHING HELPED. THE PT REQUESTED THE STIMULATOR BE REMOVED. THE DEVICE WAS EXPLANTED AND NOT REPLACED. IT WAS REPORTED THE BURNING AT THE GENERATOR SITE RESOLVED AFTER EXPLANT; TOTAL RESOLUTION AFTER EXPLANT. NO PT INJURY WAS REPORTED. THE PT RECOVERED WITHOUT SEQUELA. THE PAIN IS NOW TOLERABLE WITH MEDICATION. THE DOCTOR FELT THIS EVENT WAS RELATED TO AGGRAVATION OF THE TISSUE AT THE SITE AND WOULD HAVE OCCURRED WITH ANY DEVICE IMPLANTED AT THAT AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGEABLE LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED| LEAD MODEL 3890| EXPLANTED| EXPLANTED| LEAD MODEL 3890| EXPLANTED| LEAD MODEL 3776| PROGRAMMER MODEL 37742| RECHARGER SYSTEM MODEL 37752| EXTENSION MODEL 37081| EXPLANTED| EXPLANTED| EXTENSION MODEL 37082| LEAD (X2) MODEL UNK| IMPLANTED