BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3011807 · Received March 19, 2013

    Report

    Report Number
    3004209178-2013-03948
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Report Date
    March 1, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    THE HEALTH CARE PROVIDER CONFIRMED THE CAUSE OF THE EVENT WAS UNKNOWN. THE DEVICE WAS REPROGRAMMED ON (B)(6) 2013 WHICH PROVIDED COVERAGE IN HIS BACK. HOSPITALIZATION WAS NOT REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S STIMULATION WAS INTERMITTENT. IT WAS STATED THAT THE STIMULATION WAS SUPPOSED TO BE FOR HIS LEGS AND LOWER BACK, BUT HE SOMETIMES DID NOT FEEL IT EVEN THOUGH HE INCREASED THE STIMULATION LEVEL. IT WAS STATED THAT THE PATIENT "NEVER HAD THERAPEUTIC EFFECT." THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113760 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