BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOFIX BONE GROWTH STIMULATOR 5212

    MDR report key: 7053282 · Received November 22, 2017

    Report

    Report Number
    2183449-2017-00027
    Event Type
    Injury
    Date Received
    November 22, 2017
    Date of Event
    October 16, 2017
    Report Date
    November 17, 2017
    Manufacturer
    ORTHOFIX INC.
    Product Code
    LOF
    UDI-DI
    18257200105670
    PMA / PMN Number
    P850007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ORTHOFIX MODEL 5212 INSTRUCTION MANUAL STATES "SPINALSTIM HAS NOT BEEN EVALUATED WITH REGARD TO USE WITH SPECIFIC IMPLANTABLE ELECTRONIC MEDICAL DEVICES. PLEASE CONSULT YOUR PHYSICIAN PRIOR TO USE OF THE SPINASTIM WITH IMPLANTABLE ELECTRONIC MEDICAL DEVICES". MEDTRONIC MODEL 3037 INFORMATION FOR PRESCRIBERS MANUAL STATES " EMI FROM THE FOLLOWING EQUIPMENT IS UNLIKELY TO AFFECT THE NEUROSTIMULATION SYSTEM IF GUIDELINES ARE FOLLOWED. KEEP EXTERNAL MAGNETIC FIELD BONE GROWTH STIMULATORS 45 CM (18IN) AWAY FROM THE NEUROSTIMULATION SYSTEM.".

    Description of Event or Problem · 1

    INFORMATION PROVIDED STATES THAT DURING INITIAL TREATMENT WITH BONE GROWTH STIMULATOR PATIENT WAS PHYSICALLY SHOCKED IN HER HIP AREA WHERE SHE HAS A IMPLANTED BLADDER STIMULATOR, MEDTRONIC MODEL 3037. PATIENT HAD FOLLOW UP WITH UROLOGIST AND WAS TOLD THAT HER BLADDER STIMULATOR HAD BEEN DAMAGED BY THE BONE GROWTH STIMULATOR. PATIENT MAY REQUIRE REVISION SURGERY TO REPAIR/REPLACE HER BLADDER STIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832048 ORTHOFIX BONE GROWTH STIMULATOR 5212 BONE GROWTH STIMULATOR LOF ORTHOFIX INC. 5212 18257200105670

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other