BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 2393465 · Received December 30, 2011

    Report

    Report Number
    3007566237-2011-09388
    Event Type
    Malfunction
    Date Received
    December 30, 2011
    Report Date
    December 1, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    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.

    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 FEMALE PATIENT WAS OPERATED ON AT THE AGE OF (B)(6) BECAUSE OF AN 11-YEAR HISTORY OF PD COMPLICATED BY SEVERE FLUCTUATIONS AND LEVODOPA-INDUCED DYSKINESIAS. STN DBS RESULTED IN A SIGNIFICANT IMPROVEMENT OF MOTOR SYMPTOMS AND A REDUCTION OF THE LEVODOPA EQUIVALENT DOSAGE FROM 1,670 MG/DAY TO 750 MG AT THE 1-YEAR FOLLOWUP. IMPEDANCES OF ALL CONTACTS WERE NORMAL AFTER SURGERY, AND A MONOPOLAR STIMULATION OF CONTACTS 1 FOR THE LEFT STN (130 HZ, 60 S, 4.5 V) AND 5 FOR THE RIGHT STN (130 HZ, 60 S, 4.3 V) WAS PROGRAMMED. AFTER 1 1/2 YEARS OF DBS, SHE NOTICED A SIGNIFICANT INCREASE IN MOTOR SYMPTOMS. THE IMPEDANCE CHECK REVEALED A DISCONNECTION OF THE ACTIVE CONTACT 1 FOR THE LEFT HEMISPHERIC STN: MONOPOLAR IMPEDANCE >4,000 OHM (KINETRA), INCREASE OF THE VOLTAGE AT 130 HZ AND 60 S UP TO 8 V WITHOUT STIMULATION EFFECTS AND WITHOUT INCREASE OF THE RESTING CURRENT (15 A). ALL OTHER IMPEDANCES WERE NORMAL. DBS WAS REPROGRAMMED, RESULTING IN SATISFYING SYMPTOM CONTROL AT A MONOPOLAR STIMULATION OF CONTACTS 0 AND 2 (130 HZ, 60 S, 3.0 V). THE DISCONNECTION OF CONTACT 1 REMAINED STABLE DURING THE NEXT 1 1/2-YEAR FOLLOW-UP PERIOD. 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 LEAD MODEL NEU_UNKNOWN_LEAD LOT# UNKNOWN SERIAL#