BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 2231114 · Received August 26, 2011

    Report

    Report Number
    3004209178-2011-06906
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    June 17, 2011
    Report Date
    December 20, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE NEUROSTIMULATOR FOUND NO ANOMALIES. THE TRACE REPORT FINDINGS WERE OK. THE CONNECTOR PORTS, CONNECTOR MODULE, ACCESS HOLE ADHESIVE, GROMMETS, SETSCREWS, AND INS CAN WERE OK. TELEMETRY WAS OK. THERE WAS GOOD STABLE OUTPUT ON THE ELECTRODE PAIRS THE INS HAD WHEN RECEIVED. THERE WAS GOOD STABLE OUTPUT ON ALL ELECTRODES REFERENCED TO ONE ELECTRODE. OUTPUT WAS OK WHEN THERE WAS PRESSURE ON THE INS CAN. ANALYSIS OF THE EXTENSION FOUND NO ANOMALIES. THE PROXIMAL PORTION OF THE EXTENSION WAS OK. THERE WERE NO SETSCREW MARKS. THE CONDUCTORS AND OUTER INSULATION WERE OK. THE DISTAL PORTION OF THE EXTENSION WAS OK. CONTINUITY WAS ACCEPTABLE AND THERE WERE NO SHORTS BETWEEN CIRCUITS. ANALYSIS OF THE LEAD FOUND NO ANOMALIES. THE LEAD WAS CONNECTED TO THE EXTENSION. THE CONDUCTORS, OUTER INSULATION AND LEAD STYLET COIL WERE OK. THE DISTAL END OF THE LEAD WAS OK. CONTINUITY WAS ACCEPTABLE AND THERE WERE NO SHORTS.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF IMPLANTABLE NEUROSTIMULATOR (INS) MODEL 37711 SERIAL # (B)(4) DETERMINED NO ANOMALY WAS FOUND. GOOD, STABLE OUTPUT WAS FOUND ON ALL ELECTRODE PAIRS REFERENCED TO ONE ELECTRODE. ANALYSIS OF EXTENSION MODEL 3708140 SERIAL # (B)(4) DETERMINED NO ANOMALY WAS FOUND. THE CONTINUITY WAS ACCEPTABLE AND THERE WERE NO SHORTS BETWEEN CIRCUITS. ANALYSIS OF LEAD MODEL 377845 LOT # V002575 DETERMINED NO ANOMALY WAS FOUND. THE CONTINUITY WAS ACCEPTABLE AND THERE WERE NO SHORTS BETWEEN CIRCUITS.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    THE PT PREVIOUSLY HAD X-RAYS, AS HER LEAD WAS NOT COVERING HER PAINFUL AREAS. RESULTS OF THE X-RAYS WERE UNKNOWN. REPROGRAMMING WAS TRIED, BUT THE LEAD HAD MIGRATED TO A NON-THERAPEUTIC POSITION. THE PT HAD SURGERY TO REPLACE HER ENTIRE SYSTEM ON (B)(6) 2011. THE PT ELECTED TO REPLACE THE BATTERY AT THE SAME TIME AS SHE DID NOT WANT TO HAVE ANOTHER SURGERY TO REPLACE IT IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention IMPLANTED:| STIM ACCESSORY: MODEL 3550-29, LOT# N057229| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V002575| ACCESSORY: MODEL 37752, LOT# NKA016751N| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB000382V