BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3129530 · Received May 24, 2013

    Report

    Report Number
    3004209178-2013-08160
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 22, 2013
    Report Date
    May 6, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT FOLLOWING AN UNRELATED MEDICAL PROCEDURE 14 DAYS PRIOR. THE DEVICE WAS NOT WORKING. THE PATIENT REQUESTED REPROGRAMMING DURING A SUTURE REMOVAL PROCEDURE. IT WAS FURTHER REPORTED THAT THE PATIENT¿S LEG STIMULATION WAS NOT WORKING CORRECTLY. THE STIMULATION WAS FUNCTIONING AT A VERY HIGH RATE. IT WAS FURTHER REPORTED THAT THE PATIENT WAS TOLD 4 ELECTRODES WEREN¿T WORKING. THE PATIENT WAS IN PAIN. IT WAS REPORTED THAT A COMPANY REPRESENTATIVE MET WITH THE PATIENT AND REPROGRAMMED HER DEVICE. THE PATIENT WAS GIVEN 3 NEW GROUPS TO USE. THE PHYSICIAN FELT SHE HAD GOOD COVERAGE AND THERE WERE NO LONGER ANY STIMULATION ISSUES. THE PATIENT LEFT SATISFIED.

    Description of Event or Problem · 1

    FURTHER FOLLOW UP INFORMATION REPORTED THAT IT WAS UNDETERMINED AS TO THE CAUSE OF THE LACK OF EFFECT AND NO INTERVENTIONS WERE PLANNED. IT WAS REPORTED THAT THE PATIENT WAS DOING FINE AND RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230808 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 00052 YR