BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 8704450 · Received June 17, 2019

    Report

    Report Number
    3004209178-2019-11718
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Report Date
    June 17, 2019
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    UDI-DI
    00613994610430
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) FOR LUMBAR RADICULOPATHY AND SPINAL PAIN. INFORMATION WAS REPORTED THAT THE CALLER SAID THE PATIENT'S DEVICE HAS BEEN INACTIVE FOR 3 YEARS AND THE PATIENT IS NEEDING A SCAN OF THEIR LUMBAR SPINE. THE CALLER SAID THE PATIENT HAD A BRAIN SCAN BEFORE, BUT DOESN'T KNOW IF IT WAS WHEN THE DEVICE WAS STILL ACTIVE OR NOT. THE CALLER DID NOT KNOW THE REASON FOR THE DEVICE BEING INACTIVE. IT WAS REVIEWED THE POSSIBILITY OF AN OVERDISCHARGE AND THAT THE PATIENT WOULD AT MOST BE HEAD OR BRAIN ELIGIBLE. NO OTHER BODY PART IS RECOMMENDED TO SCAN. NO FURTHER COMPLICATIONS WERE REPORTED. NO PATIENT SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS REPORTED THAT THE CAUSE OF THE PATIENT'S BATTERY BEING INACTIVE WAS DUE TO THE BATTERY STOPPED WORKING. THE ISSUE HAS NOT BEEN RESOLVED. THE PATIENT ALSO NOTED THAT THEIR BATTERY GETS HOT IN THEIR BACK. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498883 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714 00613994610430

    Patients

    Seq Age Sex Outcome Treatment
    1