BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 8682775 · Received June 10, 2019

    Report

    Report Number
    3004209178-2019-11191
    Event Type
    Malfunction
    Date Received
    June 10, 2019
    Report Date
    June 10, 2019
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR POST LUMBAR LAMINECTOMY SYNDROME. IT WAS REPORTED THAT FOR PROBABLY THE LAST 6 MONTHS THE INS WOULDN'T HOLD A CHARGE AND NOW IT WAS LIKE IT WASN'T CHARGING AT ALL. THEY HAD AN UNRELATED SURGERY THE FOLLOWING DAY AND ASKED THE SURGEON IF THEY COULD REPLACE THE INS BUT THE SURGEON DIDN'T PERFORM INS SURGERIES. THE PATIENT WAS SENT HEALTHCARE PROVIDER LISTINGS TO DISCUSS REPLACEMENT. NO SYMPTOMS OR FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478984 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1