BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 3033379 · Received April 3, 2013

    Report

    Report Number
    6000032-2013-00080
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 29, 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
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3888-28, LOT # J0101842V, IMPLANTED: (B)(6) 2001, EXPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3888-28, LOT # J0101842V, IMPLANTED: (B)(6) 2001, EXPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 7495-66, SERIAL # (B)(4), IMPLANTED: (B)(6) 2001, EXPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 7495-66, SERIAL # (B)(4), IMPLANTED: (B)(6) 2001, EXPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTED DEVICE TURNED AND WAS PULLING ON THE WIRE. IT WAS NOTED THAT IT WAS NOT KNOWN HOW THIS HAPPENED. THERE WAS REPORTEDLY NO FALLS OR TRAUMA. THE PATIENT REPORTEDLY INQUIRED IF HE SHOULD "FLIP IT BACK." IT LATER WAS REPORTED THAT THE PATIENT'S LEADS HAD MIGRATED. IT WAS FURTHER REPORTED THAT IN 2006 AND IMPEDANCE TEST SHOWED THAT THEY NEEDED TO BE REPLACED AND ON (B)(6) 2009, THE PATIENT HAD HIS ENTIRE SYSTEM REMOVED AND REPLACED. IT WAS NOTED BY THE PATIENT THAT HIS "LEADS WERE HIGHER THAN ANYONE ELSE IN THE UNITED STATES" WHICH IS WHY IT TOOK SO LONG TO LOCATE A DOCTOR TO DO THE REPLACEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137035 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention