BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2953455 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00181
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Report Date
    November 30, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS FOUND THAT THE DEVICE HAD EVIDENCE OF BEING DROPPED SEVERAL TIMES ON THE CORNERS OF THE CASE HALVES. ANALYSIS CONFIRMED THE REPORTED EVENT, THE UPPER AND LOWER CASE HALVES WERE BROKEN, THE HEART WIRE BLOCK, ONE BATTERY LATCH O-RING, ONE BATTERY LATCH SPRING, BOTH HEART WIRE CONTACTS AND HEART LEAD FLEX WERE CONTAMINATED, BOTH BAIL COVERS AND RING COVER WERE BROKEN, TWO CASE SCREWS WERE MISSING, AND ONE BAIL AND RING WERE MISSING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CASE OF THE EXTERNAL PULSE GENERATOR WAS DAMAGED. THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS ANALYZED AND TESTED OUT OF SPECIFICATION. THERE WAS NO INDICATION GIVEN THAT THERE WAS ANY PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57840 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1