BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3592562 · Received January 27, 2014

    Report

    Report Number
    3007566237-2014-00284
    Event Type
    Malfunction
    Date Received
    January 27, 2014
    Report Date
    January 3, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT COMPATIBILITY GUIDELINES WERE REQUESTED. THE PATIENT HAD A STIMULATOR (UNKNOWN COMPANY OR TYPE, SERIAL NOT KNOWN) FOR EPILEPSY SINCE 2002 AND THE PATIENT NEEDED AN MRI OF HIS HEAD/EYES. THE PATIENT HAD BEEN HAVING VISION PROBLEMS FOR ABOUT A MONTH PRIOR TO THE REPORT. VIMPAT WAS PRESCRIBED AND THE VISION ISSUE CLEARED UP. IT WAS ALSO REPORTED THAT 2 YEARS PRIOR, THE PHYSICIAN HAD REPLACED THE STIMULATOR, BUT NO RECORDS OF THE PROCEDURE WAS KEPT AT THE PHYSICIAN¿S OFFICE. IT WAS NOTED THAT IT WAS DIFFICULT TO PROVIDE ANY MRI GUIDELINES WITH AN UNKNOWN STIMULATOR. IT WAS ALSO STATED THAT THE PATIENT HAD SHOCKS TO HIS VAGAL NERVE FROM A SHOULDER STIMULATOR. IT WAS FURTHER CLARIFIED THAT THE PATIENT WAS IN A (B)(6) STUDY, BUT THE PATIENT WAS DISCONTINUED ON (B)(6) 2010. THIS PATIENT HAD A COMPLETE EXPLANT OF THE COMPANY DEVICES. IT WAS ALSO NOTED THAT IN ORDER TO PARTICIPATE IN THE STUDY, IF THEY HAD A VAGAL NERVE STIMULATOR, IT WOULD NEED TO BE EXPLANTED. NO CURRENT DEVICES WERE FOUND IN THE COMPANY'S DEVICE REGISTRATION SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59036 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1