BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3956106 · Received July 24, 2014

    Report

    Report Number
    3004209178-2014-13505
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Report Date
    July 2, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A JOLTING SENSATION. THE PATIENT¿S SENSOR HAS BEEN ACTIVATED PRIOR BY OTHERS. SINCE THEN THE INS HAS BEEN TURNED OFF. THE PATIENT SLEEPS ON HIS LEFT HAND SIDE AND ROLLS OVER TO HIS BACK DURING THE NIGHT. DURING THAT ROLLING THE PATIENT EXPERIENCED A JOLTING SENSATION. THIS HAS BEEN OCCURRING THE PAST 1.5 WEEKS. THERE HAS BEEN NO FALLS OR TRAUMA. THERE WAS NO MULTIPLE AMPLITUDE FOR LYING RIGHT, LYING LEFT, LYING BACK. JUST ONE AMPLITUDE FOR LYING RIGHT/LEFT AND LYING BACK. THE PATIENT¿S SENSOR WAS UP UNTIL TODAY, HIS SENSOR HAS NOT BEEN ACTIVATED. THE SENSOR WAS THEN ACTIVATED TODAY. AS SOON AS THE PATIENT STARTS TO ROLL, THE INTENSITY GOES UP. IT ALSO HAPPENS WITH MOVEMENT, LIKE SITTING UPRIGHT AND THEN LEANS BACK CAN CAUSE JOLTING SENSATION. THE IMPEDANCE WAS CHECKED AND SHOWED WITHIN NORMAL RANGE. THE JOLTING SENSATION WAS ABLE TO BE REPRODUCED DURING THE IMPEDANCE CHECK. THE SENSOR RECOGNIZED THE APPARENT POSITION AND AMPLITUDE. THE PATIENT WAS REPROGRAMMED AND SEEMED TO BE DOING MUCH BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433852 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) GZB MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR