BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY PLUS

    MDR report key: 3914057 · Received July 3, 2014

    Report

    Report Number
    3004209178-2014-12532
    Event Type
    Injury
    Date Received
    July 3, 2014
    Report Date
    June 10, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7489, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION; PRODUCT ID 3998, LOT# V003655, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 7439, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S DEVICE ¿DID NOT WORK RIGHT¿ AND THEY WERE NOT COMPLETELY HAPPY WITH THE PAIN RELIEF RIGHT WHEN IT WAS REPLACED. IT WAS NOTED THAT THE PARESTHESIA NO LONGER PROVIDED PAIN RELIEF. IT WAS FURTHER REPORTED THAT THE DEVICE STOPPED HELPING THEIR PAIN A YEAR OR SO AFTER THE SECOND DEVICE WAS IMPLANTED. THE PATIENT REPORTEDLY TOLD THEIR HEALTH CARE PROVIDER (HCP) THAT IS WAS NOT WORKING FOR THEM RIGHT AFTER IT WAS IMPLANTED. IT WAS NOTED THAT THE PATIENT HAD RESOLVED TO HAVE THE IMPLANTABLE NEUROSTIMULATOR (INS) REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391796 SYNERGY PLUS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7479

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Required Intervention