BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME

    MDR report key: 5563803 · Received April 8, 2016

    Report

    Report Number
    3004209178-2016-07101
    Event Type
    Injury
    Date Received
    April 8, 2016
    Date of Event
    December 1, 2012
    Report Date
    June 15, 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

    PLEASE NOTE: THE HEALTHCARE PROVIDER IMPLANTED THE DEVICE OFF LABEL.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR OFF LABEL INDICATION. THE INDICATION THE DEVICE WAS USED FOR WAS EZW.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S DEVICE WAS IMPLANTED ON (B)(6) 2013 AND THE PATIENT WAS OK "SO FAR." ADDITIONAL INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) STOPPED WORKING IN 2015. THE PATIENT EXPERIENCED A LOSS OF STIMULATION AND A RETURN OF SYMPTOMS. THE PATIENT NOTED THAT WHEN THE HEALTH CARE PROVIDER (HCP) WHEN IN TO REPLACE THE INS, HE DID NOT FIND A BROKEN WIRE OR ANYTHING WRONG WITH THE INS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT NO ONE HAS TOLD THE PATIENT WHY THIS DEVICE FAILED. NO BROKEN WIRES OR LEADS WERE EVER DISCOVERED. IT WAS NOTED THAT WHEN THE MACHINE WORKS (FUNCTIONS) THE PATIENT ENJOY IMPROVED QUALITY OF LIFE. UNFORTUNATELY THEY SEEM TO FUNCTION FOR ONLY 18 MONTHS OR LESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220501 RESTORE PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37701

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Required Intervention