BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY VERSITREL

    MDR report key: 4232030 · Received November 6, 2014

    Report

    Report Number
    6000032-2014-00260
    Event Type
    Injury
    Date Received
    November 6, 2014
    Report Date
    October 13, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3998, LOT# LA3816, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: LEAD. PRODUCT ID: 7495LZ25, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7495LZ25, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WAS GOING TO BE TAKEN OUT AS IT NEVER WORKED AND WAS HURTING THE PATIENT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) THAT WAS GETTING EXPLANTED FOR A LACK OF THERAPEUTIC EFFECT AND HURTING THE PATIENT ALSO STOPPED WORKING DUE TO NORMAL BATTERY DEPLETION. THE INS COULD NOT BE READ. THE INS WAS EXPLANTED FOUR DAYS AFTER THE INITIAL REPORT. IT WAS FURTHER REPORTED THAT THE PATIENT WAS "HAPPY" NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715811 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 00038 YR Required Intervention