BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3210186 · Received July 8, 2013

    Report

    Report Number
    3007566237-2013-02272
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    August 1, 2011
    Report Date
    September 13, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN. PRODUCT TYPE: LEAD. OFF-LABEL USE. (B)(4).

    Additional Manufacturer Narrative · 1

    ALL PREVIOUSLY REPORTED DEVICE CODES WILL BE UPDATED/CORRECTED TO THE FOLLOWING FOR THIS EVENT: (B)(4).

    Description of Event or Problem · 1

    SERVELLO, D., SASSI, M., PACCHETTI, C., MANCINI, F., GAETA, M., RICCI, C., MENGHETTI, C., PORTA, M. HEMORRHAGIC AND REPOSITIONING RISK FACTORS RELATED TO INTRAOPERATIVE MULTITRACK MICRORECORDING ON A LARGE SERIES OF PATIENTS TREATED FOR DEEP BRAIN STIMULATION. NEUROSURGERY QUARTERLY. 2011;21(3):194-198. SUMMARY: WE ANALYZED THIS COMPLICATION IN RELATION TO SIMULTANEOUS MULTITRACK MICRORECORDING (MER) AS OBSERVED IN OUR EXPERIENCE. THE POSSIBLE CONTRIBUTION OF MER TO THE PRECISION OF THE DBS PROCEDURE WAS ALSO EVALUATED. FROM OCTOBER 1996 TO JANUARY 2010, 532 CONSECUTIVE PROCEDURES WERE PERFORMED AT THE (B)(6) BY 2 OF THE AUTHORS (D.S. AND M.S.), ON A TOTAL NUMBER OF 272 PATIENTS. FINDINGS: ISCHAEMIC/HEMORRHAGIC COMPLICATIONS WERE DOCUMENTED IN 9 PATIENTS (1.6%), AND 5 OF THEM PRESENTED WITH A NEUROLOGICAL SYNDROME. OVERALL MORTALITY WAS 3 PATIENTS (1.1%), AND WAS CORRELATED WITH INTRACRANIAL HEMORRHAGE IN 1 PATIENT. REPOSITIONING OF INCORRECTLY POSITIONED ELECTRODES WAS DEEMED NECESSARY IN 26 PROCEDURES (4.9%) ON 23 PATIENTS (8.4%). CONCLUSIONS: ALTHOUGH NO CONSISTENT ASSOCIATION WAS DOCUMENTED BETWEEN THE USE OF SIMULTANEOUS INTRAOPERATIVE MULTITRACK MER AND HEMORRHAGE, A STATISTICALLY SIGNIFICANT ASSOCIATION WAS RECORDED BETWEEN AN INCORRECT POSITIONING OF THE DEFINITIVE LEADS, AS REPORTED IN THE POSTOPERATIVE MAGNETIC RESONANCE IMAGING CONTROLS OR AT THE INTRAOPERATIVE COMPUTED TOMOGRAPHIC (CT) SCANS, AND THE LACK OF INTRAOPERATIVEMER. DBS PROVES TO BE A SAFE AND EFFECTIVE PROCEDURE EVEN FOR NOVEL INDICATIONS. IN OUR EXPERIENCE, NO ASSOCIATION WAS FOUND BETWEEN HEMORRHAGIC RISK AND SIMULTANEOUS MULTITRACK MER. REPORTED EVENT: 1 PATIENT WITH NEUROTOXICOSIS WITH BRAIN IRON ACCUMULATION HAD INCORRECT DEFINITIVE LEAD LOCATION, AND DECISION TO REPOSITION LEAD WAS TAKEN INTRAOPERATIVELY. INCORRECT POSITIONING OF THE ELECTRODES WAS DOCUMENTED BY AN INTRAOPERATIVE CT SCAN FUSED WITH THE PREOPERATIVE NEURONAVIGATIONAL PLANNING, AND THE ELECTRODES WERE REMOVED AND REPOSITIONED DURING THE SAME SURGICAL SESSION. 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
    310684 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00038 YR