BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 4240932 · Received November 10, 2014

    Report

    Report Number
    6000032-2014-00268
    Event Type
    Injury
    Date Received
    November 10, 2014
    Report Date
    October 16, 2014
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3487A-45, LOT# J0322126V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE: LEAD. PRODUCT ID: 748910, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748910, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3487A-45, LOT# J0322126V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-45, LOT# J0322126V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE: LEAD. (B)(4). ANALYSIS FOUND THAT THE ONE OF THE LEADS HAD THREE LEAD CONDUCTORS BROKEN 25.7 CM FROM THE DISTAL END. FUNCTIONAL TEST CKTS: #0 WAS OPEN, #1 WAS 143.2 OHMS, #2 AND #3 WERE OPEN. THERE WERE NO SHORTS BETWEEN CIRCUITS. THERE WERE SUSPECTED BODILY FLUIDS OBSERVED IN THE LEAD, APPROXIMATELY 70% WITH NO IMPACT ON LEAD PERFORMANCE. ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND NO ANOMALY AND WAS FUNCTIONALLY OKAY. THE INS CAN/INSULATION COATING WAS SCRATCHED. THERE WAS FOREIGN MATERIAL IN THE CONNECTOR PORTS AND BURN MARKS ON THE TITANIUM CAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS PUT IN AND HE ¿BROKE IT.¿ THERE WAS A FALL IN FEBRUARY OF 2006 AND A LOSS OF STIMULATION. AN IMPEDANCE CHECK SHOWED >4,000 OHMS ON THE LEAD. THERE WAS LEAD/EXTENSION/ACCESSORY BREAKAGE. THE LEADS WERE DAMAGED. THE ENTIRE SYSTEM AS EXPLANTED AND REPLACED. THERE WAS ALSO A REPORT OF NORMAL BATTERY DEPLETION. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED FOR THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722888 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Required Intervention