BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2881350 · Received December 20, 2012

    Report

    Report Number
    3007566237-2012-03070
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Report Date
    November 28, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE TELEMETRY ISSUES AND THE CLINICIAN PROGRAMMER INDICATED THAT THE STIMULATOR WAS NOT SUPPORTED. TWO DIFFERENT CLINICIAN PROGRAMMERS, WHICH HAD BEEN USED IN THE PAST WITH THE SAME TYPE OF STIMULATOR, WERE USED UNSUCCESSFULLY. THE TELEMETRY WAS NOT BROKEN WHEN 'STARTING BATTERY LIFE.' IF THE PROGRAMMER CARD WAS COMPATIBLE, THAT MEANT THERE WAS AN ERROR CONDITION THAT PREVENTED ANY FURTHER TELEMETRY WITH THE STIMULATOR AND A REPLACEMENT WAS NEEDED. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 37714

    Patients

    Seq Age Sex Outcome Treatment
    1