BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3875030 · Received June 16, 2014

    Report

    Report Number
    3004209178-2014-11639
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 25, 2014
    Report Date
    May 27, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    GZB
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 97792, LOT# N363786, IMPLANTED: 2014-(B)(6), PRODUCT TYPE ACCESSORY. PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: 2014-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: 2014-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS ¿MONITOR¿ WAS NOT WORKING. THE PATIENT WAS NOT FEELING STIMULATION. THE LAST TIME SHE FELT STIMULATION WAS ON 2014-(B)(6) WHEN SHE CHARGED HER IMPLANT. DURING THE REPORT, THE PATIENT WAS ADVISED TO PLACE THE ANTENNA OVER THE IMPLANT AND SYNC. THE PATIENT COULD NOT FEEL STIMULATION. THE PATIENT WAS UNCLEAR IF SHE PRESSED THE ¿STIMULATION ON¿ BUTTON. THE STIMULATION ON ICON WAS DISPLAYED ON THE PROGRAMMER. ADDITIONAL INFORMATION WAS REQUESTED, IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353066 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) GZB MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR