BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2487940 · Received March 12, 2012

    Report

    Report Number
    3007566237-2012-00515
    Event Type
    Injury
    Date Received
    March 12, 2012
    Report Date
    February 27, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL NEU_UNKNOWN_LEAD LOT# UNKNOWN SERIAL# UNK IMPLANTED: UNK EXPLANTED: UNK. THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS.

    Description of Event or Problem · 1

    LITERATURE: FAILURE OF CHRONIC PALLIDAL STIMULATION IN DYSTONIC PATIENTS IS A MEDICAL EMERGENCY JOHN YIANNI MRCS, DIPANKAR NANDI, M. CH, JONATHAN HYAM, MB, BS, VANESSA ELLIOTT, MB, BS, PETER BAIN, FRCP, RALPH GREGORY, FRCP, TIPU AZIZ, FRCS. NEUROMODULATION, VOLUME 7, NUMBER 1, 2004 9-12. ABSTRACT DEEP BRAIN STIMULATION (DBS) THERAPY IS A CONTINUALLY EXPANDING FIELD OF FUNCTIONAL NEUROSURGERY FOR THE TREATMENT OF MOVEMENT DISORDERS AND NEUROPATHIC PAIN. HOWEVER, OCCURRENCE OF ADVERSE EVENTS RELATED TO IMPLANTED HARDWARE CANNOT BE IGNORED, PARTICULARLY IN PATIENTS WITH DYSTONIC CONDITIONS. WE REPORT ON TWO SUCH PATIENTS WHO REQUIRED EMERGENCY HOSPITAL ADMISSION AND PULSE GENERATOR RE-IMPLANTATION FOLLOWING SUDDEN AND UNEXPECTED CESSATION OF DBS EFFECTIVENESS RESULTING FROM BATTERY FAILURE. REPORTED EVENT: THE POSTOPERATIVE COURSE OF THIS PATIENT WAS COMPLICATED BY THE LEFT DBS LEAD SLIPPING FROM ITS POSITION SEVERAL MONTHS AFTER SURGERY. THIS GAVE RISE TO DETERIORATION IN NEUROLOGIC FUNCTION. REVISION OF THE LEAD WAS FURTHER COMPLICATED BY INFECTION NECESSITATING REMOVAL OF BOTH DEEP BRAIN STIMULATORS, RESULTING IN FURTHER DETERIORATION TO WORSE THAN PREOPERATIVE LEVELS. THIS INCLUDED THE DEVELOPMENT OF LARYNGEAL DYSTONIA REQUIRING INTUBATION AND VENTILATION. GRADUAL SUSTAINED IMPROVEMENT IN HER CONDITION RECOMMENCED AFTER THE DBS LEADS WERE SUCCESSFULLY REPLACED FOR A SECOND TIME. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention