BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2200857 · Received August 8, 2011

    Report

    Report Number
    3007566237-2011-06136
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    June 27, 2011
    Report Date
    July 13, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOR APPROXIMATELY (B)(6), THE PATIENT EXPERIENCED HER STIMULATION SPONTANEOUSLY TURNING ON AND OFF. THE PATTERN WAS VERY INCONSISTENT. TROUBLESHOOTING TOOK PLACE MULTIPLE TIMES, BUT THE CAUSE COULD NOT BE IDENTIFIED. HOWEVER, IMPEDANCES WERE SOMETIMES LOW AT <50 OHMS ON ELECTRODES 4 AND 5. THE NEUROSTIMULATOR AND EXTENSION WERE REPLACED (THE BATTERY WAS DEPLETED AND WAS REPLACED WITH A NEUROSTIMULATOR MODEL 37713); HOWEVER, THE INCONSISTENT STIMULATION CONTINUED. THE OCTAD LEAD WAS THEN REPLACED AND STIMULATION AND IMPEDANCES WERE NORMAL. THE PATIENT INCURRED NO INJURY AND WAS FINE. REFER TO MANUFACTURER REPORT # 3007566237-2011-06139 FOR REPORT ON SUBSEQUENT DEVICE MODEL 37713.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MEDTRONIC NEUROMODULATION 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD: MODEL 3877, LOT # B0807645K| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL EXTENSION, LOT # UNK| LOT # UNK| IMPLANTABLE NEURO STIMULATOR: MODEL 37713,| EXPLANTED:| IMPLANTED:| IMPLANTED: