BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3853938 · Received June 6, 2014

    Report

    Report Number
    3004209178-2014-10261
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT THOUGHT HIS DEVICE WAS GIVING HIM TOO MUCH STIMULATION. IT WAS NOTED THAT THE REPORTER THOUGHT IT STARTED ON THE DAY OF THE REPORT. IT WAS NOTED THAT THE PATIENT WAS IN REHABILITATION. THE REPORTER NOTED THAT THE PATIENT NEEDED HELP TURNING THE STIMULATION DOWN WITH THE PATIENT PROGRAMMER. IT WAS FURTHER REPORTED THAT THE REPORTER WAS INFORMED BY THE PATIENT THAT HE HAD TOO HIGH OF STIMULATION ON THE RIGHT SIDE BUT HE DIDN¿T HAVE THE REMOTE WITH HIM. IT WAS NOTED THAT THE PATIENT WAS DOING OK BUT IT WAS STILL TOO HIGH ON THE RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331885 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97702

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR