BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3207666 · Received July 5, 2013

    Report

    Report Number
    3007566237-2013-02246
    Event Type
    Injury
    Date Received
    July 5, 2013
    Date of Event
    August 1, 2011
    Report Date
    September 13, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    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. (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 UNIT OF FUNCTIONAL NEUROSURGERY, DIVISION OF NEUROSURGERY IRCCS (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: 8. THE PATIENT HAD INCORRECT LEAD LOCATION, SO A SECOND PROCEDURE FOR LEAD REPOSITIONING WAS PERFORMED. THE DECISION TO REOPERATE WAS POSED AFTER UNSATISFYING RESULTS TOGETHER WITH POSTOPERATIVE MRI THAT DOCUMENTED INCORRECT POSITIONING OF THE LEADS. 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
    307171 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Required Intervention