BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2770155 · Received October 3, 2012

    Report

    Report Number
    3007566237-2012-02376
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 18, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS FILED AS MFR. REPORT # 3007566237. ADDITIONAL REVIEW SHOWED THE CORRECT MANUFACTURING SITE WAS SITE # (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S STIMULATOR WAS SWITCHING FROM 2.5V TO 2.0V WITHOUT THE USE OF A CONTROLLER. THE PATIENT FELT THAT THE STIMULATOR SHUT DOWN SEVERAL TIMES. THERE WERE NO PATIENT SYMPTOMS OR INJURIES REPORTED. A REPLACEMENT SURGERY FOR THE STIMULATOR WAS PLANNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE WAS REPROGRAMMED SEVERAL TIMES. THE PATIENT ALWAYS SAID THE SYSTEM WOULD "SHUT DOWN" AFTER 5 MINUTES WITHOUT USING THE PATIENT PROGRAMMER. IT WAS FURTHER REPORTED THAT THE DEVICE WAS PROGRAMMED TO 2.5 VOLTS AND AFTER SEVERAL MINUTES THE PATIENT TOLD THE PHYSICIAN THAT THE DEVICE "TURNED OFF WHILE TALKING." AN INTERROGATION OF THE DEVICE SHOWED THAT IT WAS SET TO 2 VOLTS. THE DEVICE WAS NOT SET TO CYCLING MODE AND THE PATIENT WAS IN FRONT OF THE PHYSICIAN SO IT WAS CERTAIN THAT THERE WAS NO POSSIBLE INTERACTION WITH ANOTHER DEVICE OR PROGRAMMER. THE DEVICE WAS EXPLANTED AND REPLACED AND THE PATIENT WAS RECEIVING EFFECT THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention