BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3003796 · Received March 14, 2013

    Report

    Report Number
    3004209178-2013-03689
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Report Date
    February 26, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 39565-65 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 37754 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID: 37746 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT FELT NO STIMULATION AS OF THE DATE OF THIS REPORT. THE PATIENT FELT STIMULATION THE DAY PREVIOUS. IT WAS NOTED THE PATIENT CHARGED FOR 30 MINUTES EVERY DAY. THE STIMULATION WAS REPORTED AS OFF ON THE DATE OF THIS REPORT AND THE PATIENT COULD NOT TURN IT BACK ON USING THE RECHARGER. IT WAS INDICATED, THE PATIENT NEEDED TO CHARGE THEIR DEVICE. IT WAS UNCLEAR WHY THE STIMULATION WAS OFF AND WHY THE PATIENT COULD NOT TURN IT BACK ON WITH THE RECHARGER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106574 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