BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 8545030 · Received April 24, 2019

    Report

    Report Number
    3004209178-2019-08157
    Event Type
    Malfunction
    Date Received
    April 24, 2019
    Date of Event
    January 1, 2015
    Report Date
    April 24, 2019
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3487A-45, LOT# V106112, PRODUCT TYPE: LEAD; PRODUCT ID: 3487A-45, LOT# V031037, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR THE TREATMENT OF POST LUMBAR LAMINECTOMY SYNDROME. IT WAS REPORTED THAT THE PATIENT HAD QUITE A LOT OF FALLS IN 2015. THE PATIENT REPORTED THAT THEIR INS HAS NOT WORKED SINCE 2015, AND THE LAST TIME THEY SAW THEIR DOCTOR, AN X-RAY WAS TAKEN, AND IT SHOWED THAT THE LEADS WEREN¿T CONNECTED. THE PATIENT STATED THAT THE LEADS ¿WERE CUT.¿ NO FURTHER COMPLICATIONS ARE ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340298 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR