BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3861847 · Received June 10, 2014

    Report

    Report Number
    2182208-2014-01742
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS FOUND THAT THE PATIENT OUTPUT CONNECTOR WAS BROKEN AND THE BATTERY CONTACTS WERE CONTAMINATED. AS A RESULT THE INTERCONNECT ASSEMBLY AND FLEX TAPE WERE INSPECTED AND CLEANED AND THE MAIN BOARD WAS CALIBRATED. THE BATTERY CONTACTS WERE ALSO CLEANED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONNECTOR ON THE EXTERNAL PULSE GENERATOR (EPG) WAS DAMAGED. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340423 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC, INC. 5348XS

    Patients

    Seq Age Sex Outcome Treatment
    1