BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROSTIMULATOR

    MDR report key: 2551297 · Received April 27, 2012

    Report

    Report Number
    3007566237-2012-00910
    Event Type
    Injury
    Date Received
    April 27, 2012
    Date of Event
    February 14, 2011
    Report Date
    April 18, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PATIENT. THE PATIENT INFORMATION PROVIDED IS AN AVERAGE FOR ALL THE PATIENTS.

    Description of Event or Problem · 1

    SOBSTYL, M., ZQBEK, M., DZIERZECKI, S., KOZIARA, H., MOSSAKOWSKI, Z. CHRONIC BILATERAL PALLIDAL STIMULATION IN PATIENTS WITH GENERALIZED PRIMARY DYSTONIA- MULTI-CONTACT CATHODAL STIMULATION TO BIPOLAR STIMULATION MODE, PRELIMINARY RESULTS. NEUROLOGIA I NEUROCHIRURGIA POLSKA. 2011. 45, 3; 252-259. PRIMARY GENERALIZED DYSTONIA (PGD) IS A MEDICALLY REFRACTORY PROGRESSIVE DISEASE OF THE BRAIN CAUSING NEAR TOTAL HANDICAP OF AFFECTED PATIENTS. THE AIM OF THE STUDY WAS TO ASSESS THE EFFICACY AND SAFETY OF BILATERAL PALLIDAL STIMULATION IN PATIENTS WITH PGD. THE STUDY POPULATION IS COMPOSED OF 5 PATIENTS WITH PGD. THE FORMAL OBJECTIVE ASSESSMENT INCLUDED THE (B)(6). ALL STEREOTACTIC PROCEDURES WERE PERFORMED IN GENERAL ANAESTHESIA USING A LEKSELL G STEREOTACTIC HEAD FRAME WITHOUT ELECTROPHYSIOLOGICAL GUIDANCE. IMMEDIATELY AFTER INSERTION OF DEEP BRAIN STIMULATION (DBS) LEADS, THE INTERNAL PULSE GENERATORS (ITREL II OR SOLETRA) WERE IMPLANTED SUBCUTANEOUSLY IN THE CHEST WALL OR ABDOMINAL REGION. THERE WERE NO COMPLICATIONS RELATED TO THE STEREOTACTIC PROCEDURES. THE HARDWARE-RELATED COMPLICATIONS (TWO BROKEN DBS LEADS) WERE REPLACED SUCCESSFULLY. THERE WERE NO INFECTIONS OR EROSIONS OF IMPLANTED HARDWARE. IT HAS BEEN OBSERVED THAT IN THE LONG-TERM FOLLOW-UP PERIOD PRIMARY SET BIPOLAR STIMULATION MODE LOST ITS BENEFIT ACHIEVED PREVIOUSLY. VARIOUS STIMULATION COMBINATIONS WERE INVESTIGATED. MONOPOLAR CATHODAL OR ESPECIALLY MULTI-CONTACT CATHODAL STIMULATION WAS THE MOST EFFECTIVE ONE. THE EFFICACY OF BILATERAL PALLIDAL STIMULATION WAS PROVED BY THE OBJECTIVE VALIDATED (B)(6) AT LONG-TERM FOLLOW-UP. REPORTED EVENT: DURING THE FOLLOW-UP PERIOD HARDWARE-RELATED COMPLICATIONS OCCURRED IN 2 PATIENTS (2 BREAKAGES OF DBS LEADS). ONE BREAKAGE WAS LOCATED IN PROXIMITY TO THE BURRHOLE CAP AND ONE JUST ABOVE THE CONNECTOR. ALL BREAKAGES WERE ATTRIBUTABLE TO SLIPPAGE OF THE CONNECTOR AND INCREASED TENSION EXERTED ON THE EXTRA-CRANIAL PART OF THE DBS LEAD. ALL BROKEN DBS LEADS WERE EXCHANGED UNDER GENERAL ANESTHESIA IN STEREOTACTIC CONDITIONS. THE CONNECTORS WERE PLACED IN PARIETAL REGIONS AS PREVIOUSLY BUT ADDITIONALLY SUTURED TO THE GALEAL FASCIA TO PREVENT FURTHER SLIPPAGE. THE FURTHER POSTOPERATIVE COURSE OF THESE 2 PATIENTS WAS UNEVENTFUL. ONE PATIENT DEVELOPED STERILE SEROMAS AT THE IPG SITES. THE SEROMAS REQUIRED REPEATED PROCEDURES. THE ARTICLE INCLUDED THE FOLLOWING DEVICE SPECIFICS: AFTER IMPLANTATION OF DBS LEADS, THE INTERNAL PULSE GENERATORS (IPG), ITREL II OR SOLETRA (MEDTRONIC, INC., (B)(4)), WERE PLACED IN THE SUBCLAVICULAR REGION OF THE CHEST WALL OR ABDOMINAL WALL AND CONNECTED TO THE DBS LEADS ON THE SAME DAY. 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 NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD: MODEL UNKNOWN