BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2393472 · Received December 30, 2011

    Report

    Report Number
    3007566237-2011-09392
    Event Type
    Injury
    Date Received
    December 30, 2011
    Report Date
    December 1, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONTINUATION OF CONCOMITANT MEDICAL PRODUCTS: UNK IMPLANTED: UNK EXPLANTED: UNK; LEAD MODEL NEU_UNKNOWN_LEAD LOT# UNKNOWN SERIAL# UNK IMPLANTED: UNK EXPLANTED: UNK; LEAD MODEL NEU_UNKNOWN_EXT LOT# UNK SERIAL# UNKNOWN IMPLANTED: UNK EXPLANTED: UNK; LEAD MODEL NEU_UNKNOWN_EXT LOT# UNK SERIAL# UNKNOWN IMPLANTED: UNK EXPLANTED: UNK. (B)(4).

    Description of Event or Problem · 1

    ALLERT, N., MARKOU, M., MISKIEWICZ, A., A., NOLDEN, L., KARBE, H. ELECTRODE DYSFUNCTIONS IN PATIENTS WITH DEEP BRAIN STIMULATION: A CLINICAL RETROSPECTIVE STUDY. ACTA NEUROCHIR (WIEN). 2011;153(12):2343-2349. PUBLISHED ONLINE OCTOBER 12, 2011. DOI 10.1007/S00701-011-1187-Y. SUMMARY: THIS STUDY EVALUATED THE FREQUENCY AND CLINICAL IMPLICATIONS OF ABNORMAL IMPEDANCE MEASUREMENTS. THE AUTHORS RETROSPECTIVELY ANALYZED FINDINGS OF IMPEDANCE CHECKS IN 591 CONSECUTIVE PATIENTS WITH DEEP BRAIN STIMULATION (DBS) FOR VARIOUS MOVEMENT DISORDERS TREATED BETWEEN 2005 AND 2010. DISORDERS INCLUDED PARKINSON'S DISEASE (423 PATIENTS, 132 FEMALE/291 MALE), DYSTONIA (105 PATIENTS, 45 FEMALE/60 MALE), MULTIPLE SCLEROSIS (19 PATIENTS, 11 FEMALE/8 MALE), ESSENTIAL TREMOR (31 PATIENTS, 12 FEMALE/19 MALE), AND OTHER DISORDERS (13 PATIENTS, 8 FEMALE/5 MALE). TECHNICAL DYSFUNCTIONS INCLUDED SHORT CIRCUITS, DISCONNECTIONS OF A SINGLE CONTACT OR LOOSE CONTACTS. TECHNICAL DYSFUNCTIONS WERE FOUND IN 36 OUT OF 1,142 ELECTRODES AND, AFTER REPLACEMENT OF THE IMPULSE GENERATOR, ANOTHER 16 ELECTRODES REVEALED TECHNICAL DYSFUNCTIONS. SURGERY WAS PERFORMED IN FOUR CASES WHEREAS IN THE OTHER CASES, ADJUSTMENT OF STIMULATION PARAMETERS RESULTED IN EFFECTIVE SYMPTOM CONTROL. THE AUTHORS CONCLUDED THAT TECHNICAL DYSFUNCTIONS OR ELECTRODES OR EXTENSIONS ARE RARE BUT IMPORTANT SOURCES OF UNSATISFACTORY DBS EFFICACY AND THAT REPROGRAMMING WAS AN EFFECTIVE RESOLUTION IN THE MAJORITY OF CASES. REPORTED EVENT: A PD PATIENT WAS OPERATED ON AT THE AGE OF (B)(6) BECAUSE OF A 5-YEAR HISTORY OF TREMOR-DOMINANT PD. AFTER 3 1/2 YEARS OF STN DBS THE IPG WAS REPLACED BECAUSE OF BATTERY FAILURE. SEVEN MONTHS LATER, THE IPG WAS TRANSFERRED FROM A THORACIC TO AN ABDOMINAL POSITION BECAUSE OF DISCOMFORT. FOUR MONTHS LATER, SHE COMPLAINED OF A SIGNIFICANT TREMOR INCREASE AT THE LEFT EXTREMITIES. THE IMPEDANCE CHECK OF THE RIGHT HEMISPHERIC ELECTRODE ONLY REVEALED AN ABNORMALLY LOW IMPEDANCE BETWEEN CONTACTS 0 AND 3 OF 214 OHMS. THE MAIN FINDING, HOWEVER, WAS THAT TEST STIMULATION AT CONTACTS 0 AND 1 WITH 130 HZ AND 60 MCS UP TO 8 V ONLY ELICITED DYSESTHESIA AT THE SITE OF THE CONNECTION BETWEEN THE ELECTRODE AND EXTENSION LEAD, BUT NOT THE TETANIC FACIAL CONTRACTION OBSERVED AFTER THE INITIAL DBS SURGERY 4 YEARS EARLIER AT THRESHOLDS OF 4 V. AN X-RAY DEMONSTRATED A LEAD FRACTURE OF THE STIMULATION ELECTRODE NEAR THE CONNECTION TO THE EXTENSION LEAD. THE ELECTRODE WAS SUCCESSFULLY REPLACED THEREAFTER. SEE LITERATURE ARTICLE ATTACHED IN MFR REPORT# 3007566237-2011-09387.

    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 LEAD MODEL NEU_UNKNOWN_LEAD LOT# UNKNOWN SERIAL#