BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2791351 · Received October 15, 2012

    Report

    Report Number
    2183613-2012-01594
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 10, 2012
    Report Date
    August 14, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003/S70
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: INVESTIGATION AND ANALYSIS FOUND THAT THE LEAD CONNECTION FLEX ASSEMBLY OF THE DEVICE WAS BROKEN BY THE CUSTOMER. THIS PART WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD CONNECTION ASSEMBLY WAS BROKEN ON THE EXTERNAL PULSE GENERATOR (EPG). THE EPG WAS SENT FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT INDICATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD CONNECTION ASSEMBLY WAS BROKEN ON THE EXTERNAL PULSE GENERATOR (EPG). THE EPG WAS SENT FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT INDICATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other