BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2945729 · Received February 6, 2013

    Report

    Report Number
    3004209178-2013-01361
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Report Date
    January 22, 2013
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD: PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD: PRODUCT ID 37752, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION. THE PATIENT WAS SCHEDULED FOR AN APPOINTMENT ON (B)(6) AND IT WAS NOTED THAT THE HCP WAS AWARE OF THE PATIENT'S ISSUES. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT'S DEVICE WAS REPROGRAMMED AND THE ISSUE WAS RESOLVED. AN IMPEDANCE CHECK REVEALED 2 ELECTRODES HAD HIGH IMPEDANCES, HOWEVER THE ELECTRODES WERE NOT INVOLVED IN THE ORIGINAL PROGRAMMING. NO SURGICAL INTERVENTION OR EXPLANT WAS NEEDED. IT WAS NOTED THE PATIENT'S PROGRAMMER HAD REPORTEDLY MALFUNCTIONED AND THE PATIENT HAD NO WAY TO DECREASE INTENSITY. THE PATIENT WAS TO HAVE RECEIVED A NEW PROGRAMMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50431 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