BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2398694 · Received January 5, 2012

    Report

    Report Number
    3004209178-2012-00074
    Event Type
    Injury
    Date Received
    January 5, 2012
    Report Date
    December 16, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD: MODEL 3587A, SERIAL #(B)(4), IMPLANTED: 2001 (B)(6), EXPLANTED: UNKNOWN. EXTENSION: MODEL 3708340, SERIAL # (B)(4), IMPLANTED: 2011 (B)(4), EXPLANTED: UNKNOWN. PROGRAMMER: MODEL 37743, SERIAL # (B)(4). RECHARGER: MODEL 37752, SERIAL # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING IMPLANTING A NEUROSTIMULATOR THE PATIENT WAS EXPERIENCING A WARM SENSATION IN THE POCKET AREA - OCCURRING WHEN THE STIMULATOR IS ON OR OFF. IMPEDANCE MEASUREMENTS WERE: 01: >10000, 02: >10000, 03: >10000, 12: 773, 13: 779, 23: 668, WITH ELECTRODE 0 BEING OUT OF RANGE. REPROGRAMMING WAS CONDUCTED TO 1- AND 2+ WITH NORMAL IMPEDANCE READINGS, RESULTING IN THERAPY BEING PRESENT IN THE KNEE AREA BUT NOT IN THE FEET AREA. THE PULLING AND BURNING SENSATION IN THE NEUROSTIMULATOR POCKET AREA REMAINED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    FLUID WAS FOUND UNDERNEATH THE BOOT OVER THE LEAD AND EXTENSION. THERE WAS ALSO FLUID FOUND AROUND THE LEAD INSIDE THE CONNECTOR. EVERYTHING WAS DRIED DURING A REVISION ON (B)(6) 2012. AS OF (B)(6) 2012 THE PREVIOUS PATIENT SYMPTOMS WERE GONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention