BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 2900271 · Received January 7, 2013

    Report

    Report Number
    3007566237-2013-00067
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICE: PRODUCT ID: 3389S-40, LOT#: VA04KN5, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    UPDATED ANALYSIS OF THE LEAD, LOT #VA04KN5, FOUND THAT A CROSSOVER WAS SEEN IN THE PROXIMAL END OF THE 3D X-RAY.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD (LEAD 3389S-40 STIMLOC DBS, LOT # VA04KN5) FOUND NO ANOMALY. LEAD CONDUCTORS WERE STRETCHED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAD WAS EXPLANTED. THE REPORTER STATED THAT THE BIPOLAR PAIR OF ELECTRODES 0 AND 1 SHOWED A LOW IMPEDANCE OF 31 OHMS WHEN TESTING WITH 1.5 VOLTS AND 3.0 VOLTS MULTIPLE TIMES INTRAOPERATIVELY WHEN THE LEAD WAS INITIALLY IMPLANTED. ALL OTHER BIPOLAR PAIRS WERE WITHIN THE ACCEPTABLE RANGE OF AROUND 1500 OHMS. IT WAS NOTED THAT THE NEUROSURGEON RELEASED TENSION ON THE DEPTH STOP SCREW TWO TIMES WITH IT MAKING NO DIFFERENCE. THE LEAD WAS REPLACED WITH ANOTHER LEAD. THERE WERE NO PATIENT SYMPTOMS RELATED TO THE EVENT, AND THE PATIENT SUFFERED NO INJURY OR ADVERSE EVENT. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6649 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR