BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3202791 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-11206
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 13, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: 2010-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: 2010-(B)(6), (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT. THE PATIENT STATED ¿IT DOESN¿T SEEM TO BE WORKING AS WELL AS FAR AS COVERAGE GOES.¿ THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION EVERY ONCE AND A WHILE. THERE WAS NO FALLS OR TRAUMAS NOR WERE THERE ANY CHANGES TO THE POCKET SITE. IT WAS NOTED THIS EVENT WAS ABOUT 8 MONTHS PRIOR TO THIS REPORT. THE DEVICE WAS ABOUT 8 YEARS OLD AND THE PATIENT WANTED THE DEVICE CHECKED. ADDITIONAL INFORMATION REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTH CARE PROVIDER (HCP) REPORTED THAT ON (B)(6) 2013 THE HCP SPOKE TO THE PATIENT. THERE WAS "NO ADVERSE EVENT AND NO PROBLEMS". IT WAS STATED THAT THE BATTERY WAS LOW AND NEEDED REPLACING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303082 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR