BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2231126 · Received August 26, 2011

    Report

    Report Number
    3007566237-2011-06917
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 10, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING THE IMPLANTATION OF A NEW IMPLANTABLE NEUROSTIMULATOR (THE PREVIOUS BATTERY WAS DEPLETED - SEE MANUFACTURER REPORT # 3004209178-2011-06850 FOR INFORMATION RELATED TO THAT ISSUE), IMPEDANCE READINGS WERE GREATER THAN 10,000 OHMS. MOST COMBINATIONS INVOLVING ELECTRODES 0, 1, 2 AND 3 WERE GREATER THAN 10,000 OHMS, OR GREATER THAN 3,000 OHMS. COMBINATIONS BETWEEN ELECTRODES 4 THROUGH 7 WERE ALL WITHIN THE NORMAL RANGE AND PROVIDED GOOD STIMULATION TO THE PATIENT'S RIGHT SIDE. COMBINATIONS WITH ELECTRODES 0 THROUGH 3 DID NOT PROVIDE GOOD STIMULATION. THE STIMULATION WAS NOT CHECKED INTRAOPERATIVELY, BUT IT WAS NOTED THAT IMPEDANCE READINGS WERE ELEVATED INTRAOPERATIVELY, AS WELL. IT WAS LATER REPORTED THAT THE PATIENT REQUIRED ADDITIONAL SURGERY, THE SAME DAY OF DEVICE IMPLANTATION, RELATED TO THIS ISSUE. TROUBLESHOOTING WAS PERFORMED ON THE ENTIRE DEVICE SYSTEM AND THE CAUSE OF THE PROBLEM WAS FOUND TO RELATE TO THE "TAIL" OF THE LEAD, CORRESPONDING TO ELECTRODES 0-3. THE POLYMER COATING COVERING THE LEAD HAD "COME APART" AND LEFT THE WIRES OF THE LEAD EXPOSED AT THE ANCHOR. THE NEUROSTIMULATOR WAS LEFT IMPLANTED. A NEW LEAD AND EXTENSION WERE IMPLANTED AFTER REVISION OF THE EPIDURAL SPACE. THE PATIENT, THEN, RECEIVED "GREAT" BILATERAL STIMULATION, AND WAS "VERY HAPPY" WITH THE THERAPEUTIC OUTCOME.

    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 69 YR Required Intervention EXPLANTED:| EXTENSION: MODEL 7495LZ, LOT# NHK014989V| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7495LZ, LOT# NHK014988V| PROGRAMMER: MODEL 7435, LOT# NFT022332P| IMPLANTED:| NEURO ADAPTER: MODEL 74002, LOT# UNK| LEAD: MODEL 3998, LOT# LA5092| IMPLANTED:| EXTENSION: MODEL 37082, LOT# UNK| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3998, LOT# UNK