BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY VERSITREL

    MDR report key: 5326814 · Received December 24, 2015

    Report

    Report Number
    3004209178-2015-25581
    Event Type
    Injury
    Date Received
    December 24, 2015
    Report Date
    May 18, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS USED FOR AN OFF-LABEL INDICATION. THE INDICATION THE DEVICE WAS USED FOR WAS EZW. (B)(4).

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT THE IMPLANT WAS FOR BLADDER INCONTINENCE. THE DEVICE NEVER WORKED. THE DEVICE WAS SUPPOSED TO STIMULATE BOTH SIDES BUT IT NEVER STIMULATED ON THE RIGHT SIDE. SHE ONLY FELT STIMULATION ON THE LEFT SIDE. THEREFORE, THE PATIENT NEVER HAD THERAPEUTIC SUCCESS WITH IT THAT SHE HAD HOPED FOR. THE INDICATION-FOR-USE (IFU) WAS URINARY DYSFUNCTION/SACRAL NERVE STIM. NO OUTCOME, CIRCUMSTANCES THAT LED TO THE EVENT, OR STEPS TAKEN TO RESOLVE THE ISSUE WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT THE PATIENT ENDED UP HAVING THE IMPLANTABLE NEUROSTIMULATOR (INS) TAKEN OUT ON (B)(6)-2016 BECAUSE OF PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851370 SYNERGY VERSITREL STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427V

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention