BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3793903 · Received May 6, 2014

    Report

    Report Number
    3004209178-2014-08601
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Report Date
    April 14, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7496-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 1994, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 74002, LOT# N202497, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ADAPTER. PRODUCT ID: 74002, LOT# N257771, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ADAPTER. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3487A-33, LOT# V001612, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-33, LOT# V000960, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-28, LOT# J0008023V, IMPLANTED: (B)(6) 2000, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT COULD BARELY FEEL THE STIMULATION. LAST JUNE THE PATIENT HAD A BACK SURGERY UNRELATED TO THE INS. THE HEALTH CARE PROVIDER (HCP) STATED THERE WAS ¿MOVEMENT DOWN THERE¿ IN THE PATIENT¿S SPINE AND THEY HAD TO STOP THAT MOVEMENT. THE HCP GOT THE PATIENT ON A WALKER AFTER THE PROCEDURE BUT THEY COULD HELP HIS PAIN. THE PATIENT WAS REFERRED TO PAIN MANAGEMENT WHICH IS HIS CURRENT HCP. THE HCP REPORTED THE PATIENT NEEDS STIMULATION ¿AROUND 8¿, HE NEED MORE ELECTRIC AROUND STOMACH AND HALF WAY DOWN TO THIGHS. THE PATIENT HAS TRIED OTHER INTERVENTIONS SUCH AS, HE HAD HIS NERVES CUT AND HAD SHOTS. NOTHING HAS WORKED. THE STIMULATION HAS NOT BEEN WORKING SINCE THE PATIENT HAD SPINAL SURGERY LAST JUNE. THE STIMULATION WAS STILL OFF BUT HE STILL CHARGES THE INS. AN ADJUSTMENT WAS NEEDED. THE PATIENT WOULD LIKE TO GET THE STIMULATION WORKING AGAIN DUE TO HIS PAIN SYMPTOMS AND HE WAS ANXIOUS TO GET AN APPOINTMENT FOR REPROGRAMMING. THE PATIENT WAS SEEN THE NEXT DAY AND WAS EDUCATED ON THE PROGRAMMER. THE DEVICE WAS REPROGRAMMED FOR COVERAGE. IT WAS ADDITIONALLY REPORTED THAT THE LEADS WERE REPROGRAMMED AND THE PATIENT WAS RE-EDUCATED ON HOW TO USE THE INS. NO ISSUES WITH THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270528 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR