BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3833572 · Received May 27, 2014

    Report

    Report Number
    3004209178-2014-09647
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Report Date
    May 22, 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

    PRODUCT ID: 97702, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 7495-25, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE: EXTENSION. PRODUCT ID: 74001, LOT# N271221, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: ADAPTER. PRODUCT ID: 3888-28 ,LOT# J0114065V, IMPLANTED: (B)(6) 2001, PRODUCT TYPE: LEAD. PRODUCT ID: 74002, LOT# N354737, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: ADAPTER. PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE: EXTENSION. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE: LEAD. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD TWO NEW BATTERIES IMPLANTED AND BOTH BATTERIES WERE REPLACED ON (B)(6) 2014 DUE TO NORMAL BATTERY DEPLETION. IT WAS NOTED THAT THE PATIENT MET WITH THE MANUFACTURING REPRESENTATIVE¿S FOR REPROGRAMMING AND THEY ATTEMPTED TO PROGRAM THE PATIENT TWICE BUT THEY COULD NEVER GET IT TO WHERE IT WOULD HELP THE PATIENT. IT WAS NOTED THAT THE PATIENT ¿JUST FORGOT ABOUT THE THING.¿ IT WAS NOTED THAT THE PATIENT WAS HURTING SO BAD THAT HE GOT OUT HIS PATIENT PROGRAMMER BUT COULD NOT GET IT TO DO ANYTHING. IT WAS NOTED THAT THE MANUFACTURING REPRESENTATIVE COULD NOT PROGRAM THE PATIENT TO WHERE IT WAS HELPING HIS LOWER BACK. IT WAS NOTED THAT THE PATIENT MET WITH THE MANUFACTURING REPRESENTATIVE 2 OR 3 WEEKS AFTER HE WAS IMPLANTED. IT WAS NOTED THAT THE PATIENT HAD NEVER STOPPED HURTING SINCE HIS DEVICES WERE REPLACED. IT WAS NOTED THAT THE PATIENT PROGRAMMER WOULD NOT TURN ON. IT WAS NOTED THAT THIS WAS THE FIRST TIME THE PATIENT TRIED TO TURN ON THE PROGRAMMER AND THE REPLACE PROGRAMMER BATTERIES SCREEN CAME ON. IT WAS NOTED THAT THE PATIENT WENT THROUGH ALL OF THAT PAIN AND IT WOULD NOT WORK. IT WAS NOTED THAT THE PATIENT REPLACED THE BATTERIES IN THE PROGRAMMER AND USING THE ANTENNA WAS ABLE TO SYNCH WITH THE IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THAT STIMULATION WAS SET AT 5.50 BUT STIMULATION WAS OFF. IT WAS NOTED THAT THE PATIENT TURNED STIMULATION ON AND WAS ABLE TO SEE THE LIGHTNING BOLT. IT WAS NOTED THAT THE PATIENT COULD FEEL STIMULATION BUT NOW STIMULATION WAS SET AT 5.30. IT WAS NOTED THAT THE PATIENT HIT THE WHITE BUTTON ON THE FRONT OF THE PATIENT PROGRAMMER AND STILL FELT ¿ELECTRIC¿ GOING DOWN HIS LEG. IT WAS NOTED THAT THE PATIENT THOUGHT THAT IN ANOTHER WEEK OR TWO HE WOULD SCHEDULE AN APPOINTMENT FOR PROGRAMMING. IT WAS NOTED THAT THE MANUFACTURING REPRESENTATIVE THOUGHT THAT MAYBE THE PATIENT NEEDED TO HAVE NEW WIRES PUT IN. IT WAS NOTED THAT THE PATIENT¿S WIRES WERE PUT IN 10 OR 12 YEARS AGO. THE PATIENT STATED ¿IT¿S A SON OF A GUN TO HAVE THEM PUT IN.¿ IT WAS NOTED THAT THE MANUFACTURING REPRESENTATIVE TOLD THE PATIENT THAT THE LEADS WERE OBSOLETE. REFER TO MANUFACTURER REPORT # 3004209178-2014-09646.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310429 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97702

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR