BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 4221331 · Received November 3, 2014

    Report

    Report Number
    3004209178-2014-20869
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Report Date
    October 13, 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
    TN, 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION. THE DISPLAY WAS SHOWING A ¿CALL YOUR DOCTOR¿ ICON. THE PATIENT REPORTED A POWER ON RESET (POR) CONDITION. THE POR WAS RESULT OF AN OVERDISCHARGE. THE MANUFACTURING REPRESENTATIVE MENTIONED A TRICKLE CHARGE. IT WAS NOTED THAT THERE WAS A TRIANGLE ON THE PROGRAMMER SCREEN. THE MANUFACTURING REPRESENTATIVE WAS GOING TO MAKE AN APPOINTMENT FOR THE PATIENT TO COME IN TO CLEAR THE POR. THE PATIENT HAD NOT YET BEEN ABLE TO MAKE AN APPOINTMENT TO CLEAR THE POR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S THERAPY WAS NOT WORKING. THE PATIENT DID NOT KNOW WHEN THERAPY STOPPED WORKING. LATER IT WAS REPORTED THAT THE PATIENT¿S STIMULATOR WAS NOT WORKING. THE HEALTHCARE PROFESSIONAL (HCP) STATED THAT THE PATIENT WAS NEW TO THEM. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701323 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1