BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3820419 · Received May 20, 2014

    Report

    Report Number
    3004209178-2014-09252
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Report Date
    May 14, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    GZB
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 977A290, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ¿OTHER DAY¿ PRIOR TO THE REPORT, THE PATIENT WENT INTO THE BATHROOM AND BENT DOWN TO GET AN ICEPACK, AND STIMULATION STARTED TO FEEL REALLY HIGH. THE PATIENT GOT HER PROGRAMMER AND CHECKED THE DEVICE AND STIMULATION WAS ON ¿4 SOMETHING.¿ THE LAST TIME THE PATIENT USED THE PROGRAMMER THE SETTINGS WERE ABOUT 1.35. ADDITIONAL INFORMATION WAS REQUESTED, IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT NO INTERVENTIONS WERE NEEDED FOR THE PATIENT¿S ISSUE AND THE ¿REMOTE¿ SOLVED THEIR PROBLEM. THE PATIENT WAS REPORTED AS RECEIVING EFFECTIVE THERAPY. FURTHER FOLLOW UP INFORMATION RECEIVED ON THE SAME DATE REPORTED THE PATIENT HAD CERVICAL STIMULATION AND IT WAS THOUGHT BY THEIR PHYSICIAN THAT THEY WERE NOT COMFORTABLE WITH THE TECHNOLOGY. THE MANUFACTURER¿S REPRESENTATIVE TALKED THE PATIENT THROUGH THE USE OF THE PATIENT PROGRAMMER UNIT VIA THE PHONE A COUPLE OF TIMES. THE PATIENT RECEIVED A NEW PROGRAMMER AND NO LONGER COMPLAINED OF THE STIMULATION CHANGING OR INCREASING ON ITS OWN. NO FURTHER TESTING HAS BEEN PERFORMED WITH THE PATIENT OR THEIR DEVICE AS THEY LIVED OVER 90 MINUTES AWAY FROM THE CLINIC AND DID NOT DRIVE. IT WAS REPORTED THAT THE PATIENT¿S PHYSICIAN WILL ASK THE PATIENT TO COME TO THE CLINIC OFFICE IF THE PROBLEM OCCURRED AGAIN. AS OF THE TIME OF REPORT, THE PATIENT WAS RECEIVING EFFECTIVE STIMULATION AND THAT THE STIMULATION INCREASING ON ITS OWN HAD RESOLVED WITH THE USE OF THE NEW PROGRAMMER UNIT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300580 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) GZB MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97702

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR