BEUDAMED
    FDA Adverse Event Other Summary report: N

    EP-4 CLINICAL STIMULATOR

    MDR report key: 1327510 · Received February 25, 2009

    Report

    Report Number
    2248049-2009-00002
    Event Type
    Other
    Date Received
    February 25, 2009
    Date of Event
    January 27, 2009
    Report Date
    February 24, 2009
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    JOQ
    PMA / PMN Number
    K040207
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). RECORDINGS FROM THE CASE INDICATE THE PACE MARKER SIGNAL CEASED (PER CUSTOMER, UPON HAVING EXECUTED THE HALT COMMAND). HOWEVER, THERE ARE 13 MORE INDICATIONS OF PACING (450MS X 13 = 5.85S). THERE ARE NO APPARENT PHYSICAL PROBLEMS WITH THE UNIT. UNABLE TO DUPLICATE THE COMPLAINT NOR PROVIDE PROBABLE ROOT CAUSE. THE UNIT PERFORMS PROPERLY WITHIN THE EP-4 APPLICATION AND THE SBC PASSES MEMORY TESTING. THE UNIT WILL BE FULLY FUNCTIONALLY TESTED IN SERVICE PRIOR BEFORE BEING RETURNED TO CUSTOMER. NO CORRECTIVE ACTION IS PLANNED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT AFTER HITTING THE HALT KEY TO STOP EP-4 PACING, PACING CONTINUED FOR 10 BEATS AT 450 MS DURING A CASE. THERE WAS NO PATIENT INCIDENT. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EP-4 CLINICAL STIMULATOR DIAGNOSTIC CLINICAL CARDIAC STIMULATOR JOQ ST. JUDE MEDICAL 09-1527-0002

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR NO INFORMATION