BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 4812104 · Received June 2, 2015

    Report

    Report Number
    3004209178-2015-10100
    Event Type
    Injury
    Date Received
    June 2, 2015
    Date of Event
    April 12, 2015
    Report Date
    May 12, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565-30, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NO STIMULATION SENSATION. THE PATIENT STOPPED FEELING STIMULATION IN APRIL 2015. THE PATIENT WAS USING THE PATIENT PROGRAMMER AND WAS GETTING THE DOCTOR ICON. THE PATIENT WAS GETTING AN ELECTIVE REPLACEMENT INDICATOR (ERI). THE PATIENT HAD TO CLEAR THE ERI MESSAGE AND NOW SHE WAS SEEING THE END OF SERVICE (EOS). THE PATIENT WAS TOLD BY THE DOCTOR THAT THE INS SHOULD LAST SEVERAL YEARS. THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY DEPLETION WAS BEING REPORTED AS PREMATURE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD SEEN THEIR DOCTOR ON (B)(6) 2015 AND HAS AN APPOINTMENT ON (B)(6) 2015 TO HAVE THE BATTERY REPLACED. THE PATIENT WAS VERY UNHAPPY WITH THE PRODUCT, STATING "THIS WILL BE MY THIRD BATTERY IN FOUR YEARS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357001 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97702

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention