BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY VERSITREL

    MDR report key: 2963802 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02710
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    January 28, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR REVEALED NO ANOMALY. FINAL ANALYSIS OF EXTENSION 1 ((B)(4)) REVEALED THAT THE PRODUCT WAS 'CUT THROUGH' AND 'SEGMENTED.' FINAL ANALYSIS OF EXTENSION 2 ((B)(4)) REVEALED NO ANOMALY. FINAL ANALYSIS OF LEAD 1 ((B)(4)) REVEALED THAT THE PRODUCT WAS 'CUT THROUGH' AND 'SEGMENTED.' FINAL ANALYSIS OF LEAD 2 ((B)(4)) REVEALED THE FOLLOWING: 'THE #0 CONDUCTOR WAS BROKEN 23.7CM FROM THE PROXIMAL END.' FINAL ANALYSIS OF THE ADAPTOR REVEALED NO ANOMALY.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 748910, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7489, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 64002, PRODUCT TYPE: ADAPTER. PRODUCT ID: 389045, LOT# J0537482V, IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 389045, LOT# J0537413V, IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    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 A REPORTED A "METAL CONTACT" ON THE LEAD THAT CONNECTED TO THE EXTENSION WAS "BROKEN OFF." THE OTHER LEAD WITHIN THE SYSTEM HAD IMPEDANCES THAT WERE "ON THE HIGH SIDE," BUT WERE WITHIN NORMAL LIMITS. THE PATIENT WAS NOT FEELING STIMULATION EVEN WITH THE SETTINGS "MAXED OUT." THE PATIENT HAD A REPLACEMENT SURGERY DUE TO THESE ISSUES. THE TWO LEADS AND IMPLANTABLE NEUROSTIMULATOR WERE REMOVED. PER MANUFACTURER'S DEVICE REGISTRY, IT WAS NOTED THAT TWO EXTENSIONS WITHIN THE PATIENT'S SYSTEM WERE ALSO REMOVED ON THE SAME DATE. HIGH IMPEDANCES WERE REPORTED AND BATTERY DEPLETION WAS INDICATED AS NORMAL. THE PATIENT RECOVERED WITHOUT SEQUELA. IT WAS NOTED THE PATIENT WAS GETTING "GREAT COVERAGE" AND WAS "DOING WELL." A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66910 SYNERGY VERSITREL STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427V

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention