BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 4110029 · Received September 23, 2014

    Report

    Report Number
    3004209178-2014-17543
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    July 20, 2006
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 37742, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 377775, LOT# V008355, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 377775, LOT# V008254, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S IMPLANTABLE PULSE GENERATOR (IPG) WAS REPLACED; HOWEVER, THEY STILL HAD SOME OUT OF RANGE ELECTRODES. THE PATIENT WAS PROGRAMMED AROUND THE OUT OF RANGE CONTACTS AND IS GETTING GOOD STIMULATION. THIS INFORMATION WAS PREVIOUSLY REPORTED IN REGULATORY REPORT # 3004209178-2014-15075. PREVIOUSLY REPORTED INFORMATION AND CONCOMITANT PRODUCTS CAN ALSO BE FOUND IN THE ABOVE MENTIONED REGULATORY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589735 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97712

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR