BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3983551 · Received August 6, 2014

    Report

    Report Number
    9614453-2014-01568
    Event Type
    Injury
    Date Received
    August 6, 2014
    Report Date
    July 15, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD SYMPTOMS OF A LOSS OF STIMULATION AND THERAPEUTIC EFFECT AND A BURNING SENSATION AT THE DEVICE POCKET. THE PATIENT REPORTED THAT STIMULATION WAS INTERMITTENT AND THE IMPLANTABLE NEUROSTIMULATOR (INS) TURNED OFF OFTEN, BUT TURNED ON WITH PATIENT PROGRAMMER SYNCHRONIZATION. THE PATIENT FURTHER REPORTED THAT SINCE JANUARY THE PATIENT PROGRAMMER ¿SOMETIMES¿ DISPLAYED AN ELECTIVE REPLACEMENT INDICATOR (ERI). IMPEDANCE TESTING WAS DONE AND IMPEDANCES WERE OKAY. AS A RESULT OF THE EVENT THE PATIENT WAS REPROGRAMMED. THE PATIENT STATUS AT THE TIME OF THIS REPORT WAS ALIVE WITH NO INJURY. NO PATIENT OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY DEPLETION WAS NORMAL AND THE INS WAS REPLACED. THE PATIENT WAS DOING WELL WITH THEIR NEW INS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461799 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW IPG MFG SWITZERLAND 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention