BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2230443 · Received August 15, 2011

    Report

    Report Number
    3004209178-2011-06363
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 20, 2011
    Report Date
    August 2, 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
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE PULSE GENERATOR (IPG) MODEL 37712 SERIAL (B)(4) FOUND NO ANOMALY. THE IMPLANTABLE NEUROSTIMULATOR WAS RECHARGED A TOTAL OF 4 HOURS AND 12 MINUTES FROM (B)(6) 2011. SIX TO EIGHT BARS OF COUPLING WERE OBSERVED ON THE LAST SIX RECHARGE SESSIONS. GOOD STABLE OUTPUT WAS OBSERVED ON EACH ELECTRODE PAIR. THE INSULATION COATING WAS SCRATCHED. THE IPG WAS FUNCTIONALLY OK. ANALYSIS OF THE LEAD MODEL 3778 LOT V354073007 FOUND NO SIGNIFICANT ANOMALIES. THE BODY INSULATION WAS CUT THROUGH AND THE PRODUCT WAS SEGMENTED IN SUSPECTED EXPLANT DAMAGE. THE DISTAL END WAS NOT RETURNED. ONLY A VISUAL EXAM WAS PERFORMED. ANALYSIS OF THE IPG PLUG FOUND NO ANOMALY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION. THE PATIENT HAD A LEAD REPLACEMENT SCHEDULED, AND THE REPORTER STATED THE PATIENT REQUESTED THE STIMULATOR BE REPLACED AT THE SAME TIME AS THE LEAD REPLACEMENT. IT WAS UNKNOWN WHY THE LEAD NEEDED TO BE REPLACED. THE STIMULATOR AND LEAD WERE REPLACED, AND THERE WAS NO PATIENT INJURY. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT LET THE IMPLANTABLE NEUROSTIMULATOR OVERCHARGE SEVERAL TIMES. THE BATTERY THEN WOULD NOT HOLD A CHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention EXPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE137406N| EXPLANTED:| IMPLANTED:| STIM ACCESSORY: MODEL PLUG/IPG, LOT # UNK| IMPLANTED:| LEAD: MODEL 3778, LOT# V354073007| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA133570N| EXPLANTED: