BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 4840290 · Received June 12, 2015

    Report

    Report Number
    3004209178-2015-11513
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    March 26, 2015
    Report Date
    May 26, 2015
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 977A160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 977A160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STIMULATION WAS TURNING OFF. THE REPORTER STATED THAT ABOUT 1-2 MONTHS PRIOR TO REPORT THE IMPLANTABLE NEUROSTIMULATOR (INS) TURNED OFF IN THE MIDDLE OF THE NIGHT ON THREE SEPARATE OCCASIONS. THE PATIENT CONFIRMED THAT THE INS TURNED OFF BY INTERROGATING THE DEVICE WHEN SHE WOKE UP AND IT DISPLAYED THE OFF ICON. THE PATIENT TURNED THE STIMULATOR ON WITHOUT ISSUES. THE PATIENT HAD BEEN SUCCESSFULLY USING STIMULATION SINCE IMPLANT IN (B)(6) 2014 AND HAS NOT HAD ANY OTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384895 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR