BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 2983520 · Received February 28, 2013

    Report

    Report Number
    6000032-2013-00049
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    February 5, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7495-51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2000, PRODUCT TYPE EXTENSION; PRODUCT ID 7435, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3887-33, LOT # N24075, IMPLANTED: (B)(6) 2000, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) HAD NOT BEEN FUNCTIONING SINCE 3 TO 4 YEARS PRIOR TO THE REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S DEVICE WAS "NO LONGER WORKING." IT WAS ALSO STATED THE PATIENT REFUSED TO HAVE ANOTHER SURGERY. NO FURTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87153 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7427

    Patients

    Seq Age Sex Outcome Treatment
    1