BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY VERSITREL

    MDR report key: 4047482 · Received August 29, 2014

    Report

    Report Number
    3004209178-2014-16116
    Event Type
    Malfunction
    Date Received
    August 29, 2014
    Report Date
    August 6, 2014
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION; PRODUCT ID 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT# V012107, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD; PRODUCT ID 3889-28, LOT# V010350, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD; PRODUCT ID 748910, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT HER NEUROSTIMULATOR (INS) NEEDED TO BE REPLACED BECAUSE IT WAS CAUSING PROBLEMS. THE PATIENT INDICATED THAT THE THERAPY WAS CUTTING IN AND OUT AND GETTING SHOCKING OR JOLTING SENSATION AND PAIN WHICH STARTED COUPLE MONTHS PRIOR TO THE CALL. THE PATIENT REPORTED THAT SHE SEEN SEVERAL HEALTH CARE PROVIDER (HCP) THAT TOLD HER THAT ¿INS COULD NOT BE CHANGE THE (MODULAR) MEANING IMPLANT BECAUSE IT WAS NO GOOD¿. THE PATIENT WANTED TO KNOW IF MODULAR / IMPLANT CAN BE CHANGED. THE PATIENT STATED THAT THEY WOULD HAVE TO PULL OUT 2 LEADS. THE PATIENT STATED THAT THE HCP TOLD HER THE INS THAT WAS INSIDE OF HER WAS NOT APPROVE AND NO ONE CAN DO ANYTHING WITH IT. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528682 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 00050 YR