BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2864385 · Received December 10, 2012

    Report

    Report Number
    9614453-2012-00239
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 14, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE STIMULATOR REVEALED THERE WAS NO SIGNIFICANT ANOMALY. THE STIMULATOR BATTERY WAS AT NORMAL END OF LIFE AND THE TELEMETRY AND OUTPUT WAS 'OKAY.'

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER TWO YEARS OF SUCCESSFUL THERAPY, A PATIENT SUFFERED A FALL AND HIT THE STIMULATOR WITH THE CORNER OF A TABLE. THE REPORTER STATED THAT JUST IN THAT MOMENT THE PATIENT STOPPED FEELING THE PARESTHESIA. IT WAS REPORTED THAT THE PATIENT WENT TO THE CLINIC FOR A SYSTEM REVIEW. IT WAS NOTED THAT IMPEDANCES WERE TESTED AND ALL POLES WERE BELOW 1,000 OHMS. IT WAS REPORTED THAT THE PROGRAMMER DISPLAYED THE MESSAGES "NEUROSTIMULATOR HAS REACHED THE END OF SERVICE" AND "REPLACE NEUROSTIMULATOR." THE REPORTER STATED THAT THE PATIENT HAD AN ELECTIVE NEUROSTIMULATOR REPLACEMENT. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 00034 YR Required Intervention