BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3993071 · Received August 8, 2014

    Report

    Report Number
    2183613-2014-01083
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 CONFIRMED THE REPORTED EVENT, THE MAIN PRINTED CIRCUIT BOARD (PCB) WAS OUT OF ELECTRICAL SPECIFICATION, THE DEVICE FAILED THE BATTERY REMOVAL TEST. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE EXTERNAL PULSE GENERATOR (EPG) WAS CONNECTED TO A PATIENT, THE EPG SHUT DOWN WITHOUT BACKUP PACING AFTER THE BATTERY WAS CHANGED. THE EPG WAS RETURNED TO THE MANUFACTURER FOR SERVICING. THERE WERE NO HEALTH HAZARDS DUE TO THE PATIENT HAVING AN INTRINSIC HEARTBEAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467050 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention