BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3152936 · Received June 8, 2013

    Report

    Report Number
    2182208-2013-01366
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER ANALYSIS WAS PERFORMED ON THE MAIN PRINTED CIRCUIT BOARD ASSEMBLY (PCBA). THIS ANALYSIS COULD NOT CONFIRM THE REPORTED FAILURE OF POWER UP IN CAL MODE, HOWEVER IT WAS CONFIRMED THAT THE DEVICE WAS SIGNIFICANTLY OUT OF CALIBRATION. RE-CALIBRATION PRODUCED DEVICE OPERATION WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT; THE DEVICE POWERED UP IN "CAL" MODE. THE MAIN PRINTED CIRCUIT BOARD ASSEMBLY WAS FOUND OUT OF ELECTRICAL SPECIFICATION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN THE ON BUTTON IS PRESSED THE EPG (EXTERNAL PULSE) PACEMAKER DOES NOT START PACING, IT GIVES A "CAL" ERROR IN THE RAP (RAPID ATRIAL PACING) WINDOW. ONCE THE ENABLE/DISABLE BUTTON IS PRESSED FOR THE RAP, THE MESSAGE CHANGES TO "111". THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254866 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC, INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1