BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2792704 · Received October 16, 2012

    Report

    Report Number
    3004209178-2012-09226
    Event Type
    Malfunction
    Date Received
    October 16, 2012
    Report Date
    September 18, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 377875, LOT# V005100, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: LEAD: PRODUCT ID 377875, LOT# V005100, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: LEAD: PRODUCT ID 37752, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) DISCHARGED WITHIN ONE DAY. THE PATIENT THEN RECHARGED AND THE NEXT MORNING WHEN THEY TURNED THE INS BACK ON, THEY EXPERIENCED A SHOCKING SENSATION, NOTED THAT THE COVERAGE FOR THEIR PAIN WAS "DIFFERENT", AND COULD NOT TURN THE INS OFF. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. SEE ALSO MANUFACTURER'S REPORT # 3004209178-2012-09072 FOR THE PATIENT'S ISSUE RELATED TO SKIN BREAK DOWN DURING RECHARGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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