BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2485792 · Received March 9, 2012

    Report

    Report Number
    3007566237-2012-00512
    Event Type
    Injury
    Date Received
    March 9, 2012
    Date of Event
    November 2, 2004
    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

    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

    ADDITIONAL INFORMATION FROM THE PATIENT'S HEALTH CARE PROVIDER (HCP) SHOWED THE BATTERIES DEPLETED DUE TO HIGH SETTINGS USED FOR DYSTONIA.

    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. SUMMARY: 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: PATIENT WAS A YOUNG GIRL WITH A HISTORY OF DYT1-NEGATIVE IDIOPATHIC DYSTONIA. PATIENT WAS IMPLANTED WITH DUAL DBS SYSTEMS, AND SHOWED IMPROVEMENT IN HER CONDITION. PROGRESS WAS IMPEDED BY SUDDEN BATTERY FAILURE AT 27 MONTHS. OVER THE SPACE OF 24 HR, HER CONDITION DETERIORATED. BATTERY CHECK CONFIRMED THAT BATTERY OF THE PULSE GENERATOR HAD RUN OUT. PHENOTYPICALLY HER APPEARANCE WAS RAPIDLY PROGRESSING TO THAT PRIOR TO HER FIRST OPERATION. AN URGENT IPG CHANGE WAS PERFORMED. WITHIN 24 H OF RECOMMENCING STIMULATION HER CONDITION IMPROVED. FURTHER CONTINUED IMPROVEMENT HAS OCCURRED SINCE. 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