BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 4100017 · Received September 18, 2014

    Report

    Report Number
    3004209178-2014-17332
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Report Date
    September 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 97740, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 9 7754, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THEY WERE PROGRAMMED WITH ADAPTIVE STIMULATION WITH DIFFERENT BODILY POSITIONS BUT IT ¿DID NOT WORK AT ALL¿. THE PATIENT WANTED TO GO BACK TO THEIR OLD MANUAL SETTINGS BUT WASN¿T ABLE TO GET BACK TO THE MANUAL SETTINGS. THE PATIENT WANTED TO MEET WITH A MANUFACTURER REPRESENTATIVE BECAUSE, THEY WERE UNABLE TO FOLLOW THE INSTRUCTIONS OVER THE PHONE. THEIR MANUAL SETTINGS WERE PROGRAMS A AND B FOR EACH LEG. INFORMATION WAS OMITTED PERTAINING TO EVENT (B)(6) ¿ RECHARGING ISSUES. NO INTERVENTION OR OUTCOME WAS PROVIDED HOWEVER ADDITIONAL INFORMATION WAS REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578450 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR