BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 4995388 · Received August 12, 2015

    Report

    Report Number
    3004209178-2015-15857
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Date of Event
    July 20, 2015
    Report Date
    July 20, 2015
    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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: 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: 2015-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: 2015-(B)(6), PRODUCT TYPE LEAD. (B)(4)

    Description of Event or Problem · 1

    THE MANUFACTURER REPRESENTATIVE REPORTED VIA THE PATIENT THAT FOLLOWING A LEAD REVISION AND IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT IN (B)(6) OF 2015 THAT THE STIMULATION WAS NOT HELPING AND WAS NOT IN THE RIGHT LOCATION. THE ADAPTIVE STIMULATION WAS JOLTING THE PATIENT SO THEY REQUESTED IT BE TURNED OFF. THIS WAS OCCURRING WHEN THE PATIENT WAS WALKING AND STOPPING BUT RESOLVED WHEN THEY CHANGED POSITIONS. UPON INTERROGATION IT APPEARED THAT THE SETTINGS WERE HIGHER IN DIFFERENT POSITIONS; UPRIGHT AT 8.0V AND MOBILE AT 9.2V. REPROGRAMMING COULD ONLY PRODUCE STIMULATION AT THE INSIDE OF THEIR LEGS INSTEAD OF THE BACK. AS A RESULT, TWO HIGH DEFINITION GROUPS WERE ADDED; GROUP F AT 190US AND 660HZ AND GROUP G AT 800 US AND 300HZ. NO FURTHER INTERVENTIONS WERE PLANNED. THE PATIENT WAS GOING TO TRY OUT THE NEW GROUPS AND SEE IF IT HELPED THEM. INDICATIONS FOR USE ARE AS FOLLOWS: 903 SPINAL PAIN 043 FAILED BACK SURGERY SYNDROME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529989 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR