BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3790008 · Received May 5, 2014

    Report

    Report Number
    3007566237-2014-01230
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED BY THE PATIENTS PHYSICIAN THAT AS OF (B)(6) 2014, THE BATTERY STILL WAS NOT WORKING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S STIMULATOR WAS REPLACED DUE TO NORMAL DEPLETION. A NEW DEVICE WAS PLACED WITH AN ADAPTOR AND IMPEDANCES WERE OUT OF RANGE. ELECTRODES 0/3 WERE LESS THAN 150 OHMS. POST OPERATIVELY, COMBINATIONS USING ELECTRODES 0, 1, 2 HAD IMPEDANCES RANGING FROM 4,914 OHMS TO 6,986 OHMS. THE PATIENT HAD NO STIMULATION POST OPERATIVELY, EVEN AT 10.5V. MULTIPLE COMBINATIONS WERE TRIED. THE COMPANY REPRESENTATIVE PLANNED TO LET THE DEVICE SETTLE AND TEST AGAIN SOON. IT WAS FURTHER REPORTED THAT THE PATIENT HAD NOT BEEN SEEN AS OF (B)(6) 2014. STIMULATION HAD NOT BEEN TURNED ON. THE PLAN WAS TO RUN ANOTHER IMPEDANCE TEST AT THE NEXT APPOINTMENT. IF ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268932 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) GZB MEDTRONIC NEUROMODULATION 97702

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR