BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3863422 · Received June 10, 2014

    Report

    Report Number
    2182208-2014-01681
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. PRODUCT EVENT SUMMARY: ANALYSIS FOUND THAT THE CONNECTOR JOINT ON THE CABLE WAS BROKEN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NO PACING WHILE CONNECTED TO A PATIENT WHILE USING THE PATIENT CABLE. THERE WAS CONCERN THAT THE CABLE WAS NOT WORKING PROPERLY. THE CABLE WAS RETURNED TO THE MANUFACTURER. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339211 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC, INC. 5433V

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 5388 EXTERNAL PULSE GENERATOR