BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3965236 · Received July 29, 2014

    Report

    Report Number
    3007566237-2014-02109
    Event Type
    Injury
    Date Received
    July 29, 2014
    Report Date
    July 7, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3877-45, LOT# 0207320134, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 37081-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3877-45, LOT# 0207320134, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4). ANALYSIS FOUND THAT ALL CONDUCTORS WERE BROKEN ON THE LEAD AT AN UNKNOWN ANCHOR SITE. THE CONDUCTORS WERE BROKEN 22.6 CM FROM THE PROXIMAL END. THE OUTER INSULATION WAS ABRADED AND HAD ESC 27.5 CM FROM THE PROXIMAL END.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION CHANGED THE CLINICAL DIAGNOSIS TO PAIN IN THE LEG AND STIMULATION NOT WORKING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT X-RAY TRAJECT NEUROMODULATION SYSTEM STIMULATION WENT OFF AND ON, WHILE THE NEUROMODULATION SYSTEM WAS ENABLED. THE EVENT WAS RELATED TO THE LEAD AND REQUIRED IN PATIENT HOSPITALIZATION AND AN UNSCHEDULED CLINIC OR OFFICE VISIT. THE LEAD WAS EXPLANTED AND THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE. THE PATIENT'S STATUS WAS NOT AVAILABLE AS OF THE DATE OF THE REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD WAS FRACTURED AT THE ANCHOR SITE SUSPECTED BY THE IMPLANTER. THE PATIENT FELT SHOCKING STIMULATION WHILE USING THE DEVICE NORMALLY. IMPEDANCE TESTING WAS DONE AND THE LEAD WAS REPLACED. INFORMATION RECEIVED ABOUT A WEEK AND A HALF LATER IT WAS NOTED THAT ¿MAJORITY¿ OF THE IMPEDANCES WERE GREATER THAN 10,000 OHMS. IT WAS UNKNOWN WHY THE LEAD WAS FRACTURED. FOLLOWING THE REPLACEMENT, THE PATIENT WAS DOING WELL AND RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442259 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW IPG MFG SWITZERLAND 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R