BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 2251167 · Received September 8, 2011

    Report

    Report Number
    3004209178-2011-07577
    Event Type
    Malfunction
    Date Received
    September 8, 2011
    Report Date
    December 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT COULD NOT ADJUST STIMULATION AND A 'CALL YOUR DOCTOR' ICON WITH A CODE 006 WAS SHOWN.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A JOLT UP HER SPINE AFTER THE INS SWITCHED GROUPS ON ITS OWN. THE PATIENT WAS AT HOME AND INCREASED THE STIMULATION SETTING ON GROUP B. THE STIMULATION BECAME TOO STRONG SO SHE TURNED THE INS OFF. WHEN SHE TURNED IT BACK ON THE INS WAS ON GROUP A AT 6.0V AND 5.75V WHICH WAS A MUCH HIGHER SETTING THAN GROUP B. HER INS WAS CHANGED BACK TO GROUP B AT A SETTING OF 2.9V FOR PROGRAM 1 AND 4.70V FOR PROGRAM 2. THE PATIENT PROGRAMMER SHOWED THE INS "ON" AND "FULL BATTERY" ICONS. THE PATIENT'S HEALTH CARE PROFESSIONAL TOLD HER THAT ELECTRODES 0 AND 1 ARE OUT AND THE REST OF THE LEAD WAS CURVED TO ONE SIDE AND NEAR NERVES. THE INS WAS GOING TO BE REPLACED BUT THE DATE WAS UNKNOWN. IT WAS NOTED THAT THE RECHARGER SHOWED THE RECHARGE SCREEN EVEN THOUGH IT WAS NOT OVER THE INS. THE COUPLING BOXES WERE PRESENT AND ALL 8 WERE SHADED WHEN THIS OCCURRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD034956N| LEAD: MODEL 377745, LOT# V001706