BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 5085186 · Received September 17, 2015

    Report

    Report Number
    3004209178-2015-18182
    Event Type
    Malfunction
    Date Received
    September 17, 2015
    Report Date
    August 26, 2015
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3888-45, LOT# V386351, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT# V375109, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3986A, LOT# N140442, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-45, LOT# V029694, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3986A, LOT# N138329, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3550-09, LOT# LC3722, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 37082-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37082-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED INTERMITTENT/ERRATIC THERAPY AND A LOSS OF THERAPY. THERAPY DIDN'T SEEM TO BE WORKING AND THEY WERE INCREASING STIMULATION QUITE HIGH. THE ONLY TIME SHE WOULD FEEL STIMULATION WAS WHEN SHE WOULD COUGH OR LAUGH. SHE WAS NOT GETTING RELIEF FROM THE THERAPY. THE SETTING WAS UP TO 70 VOLTS AND SHE WAS NOT FEELING ANYTHING. IT WAS NOTED THAT SHE DID NOT HAVE AN HCP. SHE WANTED REPROGRAMMING. THEN IT WAS STATED SHE HAD A PRIMARYHCP. THE PATIENT DISCONNECTED THE CALL. RELEVANT MEDICAL HISTORY INCLUDED CERVICAL RADICULOPATHY. FOLLOW-UP WAS PERFORMED TO DETERMINE WHAT ACTIONS WERE TAKEN TO ADDRESS THE REPORTED ISSUES AND IF THE ISSUES WERE RESOLVED. THIS EVENT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614537 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