BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2393417 · Received December 30, 2011

    Report

    Report Number
    3007566237-2011-09387
    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

    CONCOMITANT MEDICAL PRODUCTS: LEAD MODEL NEU_UNKNOWN_LEAD (N=52) LOT# UNKNOWN SERIAL#UNK IMPLANTED: UNK EXPLANTED: UNK; MODEL 7426 LOT# UNK SERIAL# UNKNOWN IMPLANTED: UNK EXPLANTED: UNK; MODEL 37612 LOT# UNK SERIAL# UNKNOWN IMPLANTED: UNK EXPLANTED: UNK; MODEL 37601 LOT# UNK SERIAL# UNKNOWN IMPLANTED: UNK EXPLANTED: UNK. IT WAS NOT POSSIBLE TO MATCH THESE EVENTS WITH PREVIOUSLY REPORTED EVENTS. (B)(4): "BATTERY FAILURE" AND "HARDWARE FAILURE."

    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 EVENTS: A TECHNICAL DYSFUNCTION WAS FOUND IN 36 OUT OF 1,142 ELECTRODES IN THE OBSERVATION PERIOD FOLLOWING IMPLANT: 22 ELECTRODES HAD SHORT CIRCUITS, 8 ELECTRODES HAD DISCONNECTIONS OF SINGLE CONTACTS, AND 6 ELECTRODES HAD LOOSE CONTACTS. THERE WERE 109 IPG STIMULATOR REPLACEMENTS DUE TO "BATTERY FAILURE" OR "HARDWARE FAILURE." FOLLOWING THE 109 REPLACEMENTS, AN ADDITIONAL 16 ELECTRODES EXHIBITED DYSFUNCTIONS IN THE OBSERVATION PERIOD FOLLOWING REPLACEMENT: 9 ELECTRODES HAD SHORT CIRCUITS, 5 ELECTRODES HAD DISCONNECTIONS OF SINGLE CONTACTS, AND 2 ELECTRODES HAD LOOSE CONTACTS. SURGICAL REVISION WAS PERFORMED IN 4 OF THE OVERALL 52 ELECTRODES WITH DYSFUNCTION; 3 RESULTED DIRECTLY IN SURGICAL REVISION WHILE 1 OTHER ELECTRODE WITH A SHORT CIRCUIT WAS REPLACED PRIMARILY BECAUSE OF A SIGNIFICANT DISLOCATION. IN THE OTHER ELECTRODES, ADJUSTMENT OF STIMULATION PARAMETERS RESULTED IN STABLE AND SATISFYING SYMPTOM CONTROL. ONE ELECTRODE HAD TO BE REPLACED DUE TO WOUND DEHISCENCE 9 MONTHS AFTER SURGERY AND SHOWED A STABLE SHORT CIRCUIT OF CONTACTS THEREAFTER. ONE IPG WAS REPOSITIONED BECAUSE OF TENSION BETWEEN THE EXTENSION LEAD AND THE ABDOMINALLY PLACED IPG, WHICH HAD RESULTED IN PROGRESSIVE DISCONNECTION OF CONTACTS 10 AND 11 OF THE RIGHT HEMISPHERIC ELECTRODE DURING HOSPITAL REHABILITATION 2 WEEKS AFTER IMPLANTATION (MONOPOLAR IMPEDANCES OF CONTACTS 10 AND 11 AT ADMISSION: 975 OHMS AND 955 OHMS, RESPECTIVELY, AND 2 WEEKS LATER BOTH >40,000 OHMS). ONE PD PATIENT 6 MONTHS AFTER AN IPG REPLACEMENT AND 4 1/2 YEARS AFTER DBS IMPLANTATION NOTICED THAT PRESSURE ON THE CONNECTION BETWEEN ELECTRODES AND EXTENSION LEADS RESULTED IN SUDDEN DOUBLE VISION AND DYSAESTHESIA OF THE LEFT ARM, SUGGESTING INTERMITTENT SHORT CIRCUIT OF THE ACTIVATED DORSAL CONTACT 3 TO MORE VENTRAL CONTACTS. AN X-RAY DEMONSTRATED A DEVIATION OF THE THIRD OF FOUR SETSCREWS AT THE CONNECTION BETWEEN EXTENSION LEAD AND ELECTRODE. INTRA-OPERATIVELY A DEFECT OF BOTH THE EXTENSION LEAD AND THE ELECTRODE WAS FOUND, AND BOTH WERE SUCCESSFULLY REPLACED.

    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