BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2821525 · Received November 6, 2012

    Report

    Report Number
    3004209178-2012-09965
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Report Date
    October 8, 2012
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37744, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE DEVICE HAD TURNED OFF "FOR NO REASON" 2 TIMES. THE PATIENT LOST STIMULATION AND CHECKED WITH THE PATIENT PROGRAMMER TO VERIFY THE DEVICE WAS OFF. THE PATIENT COULD NOT ISOLATE WHERE THE EVENT OCCURRED. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD GREAT THERAPEUTIC EFFECT AND STIMULATION WAS EFFECTIVE. EVERYTHING WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) "SEEMED FINE." THE PATIENT WAS TOLD TO DOCUMENT IN THE FUTURE ANY SITUATION WHERE THE STIMULATION WAS OFF AND CIRCUMSTANCES OF IT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1