BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY VERSITREL

    MDR report key: 5243492 · Received November 23, 2015

    Report

    Report Number
    3004209178-2015-23277
    Event Type
    Injury
    Date Received
    November 23, 2015
    Report Date
    November 3, 2015
    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. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-28, LOT# V287787, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 748910, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3093-28, LOT# V287787, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 748910, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    THE HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE PATIENT HAD THE IMPLANTABLE NEUROSTIMULATOR (INS) REMOVED. IT WAS REMOVED ONE DAY AFTER IT WAS IMPLANTED AND IT WAS REMOVED BECAUSE THE INS DID NOT DO ANYTHING. THE INDICATION-FOR-USE (IFU) WAS URINARY DYSFUNCTION/SACRAL NERVE STIM. NO OUTCOME, CAUSE, OR TROUBLESHOOTING PERFORMED WAS 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774656 SYNERGY VERSITREL STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427V-NP

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Required Intervention