BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4210934 · Received October 29, 2014

    Report

    Report Number
    3004209178-2014-20623
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Report Date
    October 8, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING INTERMITTENT STIMULATION THAT WAS, AT TIMES, POSITION DEPENDENT. IMPEDANCE TESTING SHOWED THAT CONTACT 6 HAD HIGH IMPEDANCES WITH A VALUE OF GREATER THAN 10,000 OHMS. CONTACT 6 HAD BEEN BEING USED AS A CATHODE. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPROGRAMMED TO NOT USE CONTACT 6 AND THE PATIENT WAS HAPPY WITH THE RESULTS. THE STIMULATION WAS COVERING ALL OF THE PATIENT¿S PAIN AREAS AFTER REPROGRAMMING. NO FURTHER FOLLOW-UP WAS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693328 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1