BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 4121752 · Received September 26, 2014

    Report

    Report Number
    3004209178-2014-17796
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 1, 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
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 39565-65, LOT# 0204364533, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT PROGRAMMER DISPLAYED A POWER ON RESET (POR). THE PATIENT HAD A RECHARGEABLE IMPLANTABLE NEUROSTIMULATOR (INS) AND THEY KEPT THE INS CHARGED. FOLLOW UP WITH THE MANUFACTURING REPRESENTATIVE INDICATED THE POR WAS NOT CLEARED AND THE PATIENT WAS GOING INTO THE CLINIC THE FOLLOWING (B)(6) FOR FURTHER INVESTIGATIONS. THE PATIENT HAD X-RAYS AND A CT RECENTLY AND THEY HAD GONE THROUGH A BODY SCANNER AT AN AIRPORT, BUT THE CAUSE OF THE POR WAS UNKNOWN. THE POR HAD ONLY OCCURRED ONCE. THE PATIENT WAS GETTING SOME THERAPY, BUT LESS COVERAGE AND EFFICACY THAN BEFORE THE POR. AT THE PATIENT¿S APPOINTMENT ON (B)(6) THE INS WAS INTERROGATED AND IMPEDANCES WERE ACCEPTABLE. THE MANUFACTURING REPRESENTATIVE RE-ENTERED THE LEAD DATA AND ACTIVATED THE SAME PROGRAM AS BEFORE WITH MINOR ADJUSTMENTS AND THE PATIENT¿S STIMULATION RETURNED. A SECOND PROGRAM WAS ADDED FOR LYING DOWN AND THE PATIENT HAD GOOD COVERAGE AND THEY WERE HAPPY WITH THE INS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601700 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