BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 3162564 · Received June 11, 2013

    Report

    Report Number
    6000032-2013-00149
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 21, 2013
    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
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 7495-66, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7495-66, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3998, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, WHEN PATIENT'S DOCTOR INITIALLY IMPLANTED THE BATTERY, THE STIMULATION WAS NOT COVERING HER PAIN. THE HEALTH CARE PROVIDER REPORTED THAT THE PATIENT WAS IN A MOTOR VEHICLE ACCIDENT IN 2002. SHORTLY AFTER THE ACCIDENT, THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS EXPLANTED, BUT THE LEADS WERE LEFT IN PLACE. IT WAS STATED THAT THERE WAS HOSPITALIZATION AND A SERIOUS INJURY DUE TO THE CAR ACCIDENT. IT WAS REPORTED THAT THE PATIENT DID RECOVER WITHOUT SEQUELA. THE PATIENT WAS IMPLANTED WITH A NEW STIMULATOR ABOUT TENS YEARS LATER. INFORMATION ON THE CURRENT DEVICE IS IN MANUFACTURER REPORT # 3004209178-2013-04356.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262487 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7427

    Patients

    Seq Age Sex Outcome Treatment
    1