BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 5068477 · Received September 10, 2015

    Report

    Report Number
    3004209178-2015-17732
    Event Type
    Malfunction
    Date Received
    September 10, 2015
    Date of Event
    May 12, 2015
    Report Date
    August 18, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT(S): PRODUCT ID: 377860, LOT# V013243, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 377860, LOT# V013243, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT HE HAD HIS HIP REPLACED ON THE SAME SIDE AS THE IMPLANTABLE NEUROSTIMULATOR (INS). THEY CUT ALL THE WAY UP ALMOST TO THE BATTERY. THE SURGERY WAS SCHEDULED FOR (B)(6) 2015. THE PATIENT LATER REPORTED THAT THE DEVICE WAS TURNED OFF DURING SURGERY FOR HEART MONITORING. THE PATIENT HAD A CONCERN ABOUT THE SETTINGS FOLLOWING SURGERY. ALL SETTINGS REVEALED THE SAME WITH MINIMAL ADJUSTMENTS, ESSENTIALLY LITTLE TO NO EFFECT. NO NOTABLE SYMPTOMS WERE REPORTED TO THE INCISION BEING SO CLOSE TO THE INS. THE INCISION WAS SEALED WITH ADHESIVE AND HE FELT NOT DISCOMFORT AROUND THE DEVICE, WHICH WAS TURNED BACK ON IMMEDIATELY AFTER SURGERY. IT WAS NOTED THAT THE PATIENT WAS IMPLANTED FOR CHEST WALL AND LUMBAR RADICULOPATHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598447 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR