BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3811320 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-08972
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    May 27, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: 2013-(B)(6), EXPLANTED: 2014-(B)(6), PRODUCT TYPE LEAD, PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER. PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: 2014-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: 2013-(B)(6), EXPLANTED: 2014-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A LAMINECTOMY LEAD PLACED AND THEIR PERCUTANEOUS LEADS REMOVED. IT WAS NOTED THE PATIENT HAD NOT BEEN EXPERIENCING STIMULATION IN THEIR DESIRED AREAS. IT WAS REPORTED THE PATIENT WAS GETTING STIMULATION IN THE DESIRED LOCATIONS FOLLOWING THE REVISION. IT WAS NOTED THE PATIENT HAD A FOLLOW-UP APPOINTMENT SCHEDULED FOR FOUR WEEKS AFTER REVISION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS REPROGRAMMED ONE WEEK PRIOR TO REPORT AND IS NOW FEELING STIMULATION IN THEIR DESIRED AREAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291140 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 Required Intervention