BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2485648 · Received March 9, 2012

    Report

    Report Number
    3007566237-2012-00509
    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

    CONTINUATION OF CONCOMITANT MEDICAL PRODUCTS: LEAD MODEL NEU_UNKNOWN_LEAD LOT# UNKNOWN SERIAL# UNK IMPLANTED: UNK EXPLANTED: UNK; LEAD MODEL NEU_UNKNOWN_LEAD LOT# UNKNOWN SERIAL# UNK IMPLANTED: UNK EXPLANTED: UNK. THE ACTUAL EVENT DATES WERE NOT PROVIDED. 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 (B)(6) WOMAN, TWENTY-TWO MONTHS POSTIMPLANTATION AND 7 MONTHS PREGNANT. THE PATIENT WOKE ONE MORNING WITH SEVERE AND PAINFUL RETROCOLLIS, WORSE THAN PREOPERATIVE LEVELS. SHE ALSO EXPERIENCED A RAPID RETURN OF HER DYSTONIC TREMOR, ESPECIALLY IN THE NECK AND RIGHT ARM, TOGETHER WITH MARKED DYSTONIC POSTURING OF THE LEFT FOOT. A STIMULATOR CHECK REVEALED BATTERY FAILURE. THE KINETRA PULSE GENERATOR BOX WAS REPLACED THAT NIGHT AS AN EMERGENCY. WITHIN HOURS OF RECOMMENCING STIMULATION THERE WERE IMPROVEMENTS IN HER DYSTONIC SYMPTOMS ALMOST TO THE LEVEL PRIOR TO DETERIORATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE. SEE ATTACHED LITERATURE ARTICLE.

    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 00025 YR Required Intervention LEAD