BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 4025519 · Received August 20, 2014

    Report

    Report Number
    3004209178-2014-15659
    Event Type
    Malfunction
    Date Received
    August 20, 2014
    Date of Event
    July 29, 2014
    Report Date
    July 30, 2014
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37742, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3 77760, LOT# V004017, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 355029, LOT# N060623, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED, THE PATIENT DID NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY. A MANUFACTURING REPRESENTATIVE HAD ANSWERED ALL OF THE PATIENT'S QUESTIONS ABOUT THE SAFETY OF HAVING A MYELOGRAM WITH AN IMPLANTABLE NEUROSTIMULATOR (INS).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A CT SCAN OF THEIR BACK THE DAY PRIOR TO THE REPORT. THE PATIENT DIDN¿T TURN THE STIMULATION DOWN TO 0 BEFORE THE CT SCAN. WHEN THEY TRIED TO TURN THE STIMULATION ON AT THE TIME OF THE REPORT THEY WERE NOT FEELING IT AND IF THEY INCREASED THE STIMULATION IT BECAME UNCOMFORTABLE. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501868 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR