BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY VERSITREL

    MDR report key: 3221274 · Received July 11, 2013

    Report

    Report Number
    6000032-2013-00168
    Event Type
    Injury
    Date Received
    July 11, 2013
    Report Date
    June 18, 2013
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 7495LZ51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3550-09, LOT# LA6911, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3587A, LOT# LA5915, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WORKED GREAT UNTIL IT ¿DIED¿ IN 2004, TWO YEARS AFTER IT WAS IMPLANTED. IT WAS STATED WHEN THE PATIENT WENT TO HAVE THEIR INS REPLACED THEY GOT A STAPH INFECTION. IT WAS NOTED THE INS WAS REMOVED DUE TO THE STAPH INFECTION AND THE INFECTION HAD TO BE ¿SUCKED OUT OF THE BODY.¿ REPORTEDLY, THE INS WAS NEVER REIMPLANTED AND THE PATIENT WANTED TO GET OFF ORAL MEDICATION AND GET A NEW INS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320675 SYNERGY VERSITREL STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7427V

    Patients

    Seq Age Sex Outcome Treatment
    1 00025 YR Required Intervention