BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2952871 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00158
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    December 26, 2012
    Report Date
    December 26, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE BATTERY DRAWER AND BATTERY RELEASE WAS CONTAMINATED. IT WAS ALSO NOTED THAT THE LOWER CASE WAS BROKEN, BATTERY COMPARTMENT IN LOWER CASE WAS CONTAMINATED, THE MAIN PRINTED CIRCUIT BOARD (PCB) WAS OUT OF SPECIFICATION, BOTH BAIL COVERS WERE BROKEN, THE RING COVER WAS BROKEN, THE BATTERY CONTACTS WERE COMPRESSED, THE BATTERY DRAWER WAS DAMAGED AND THE SERIAL NUMBER LABEL WAS DAMAGED. FURTHER ANALYSIS WAS PERFORMED ON THE MAIN PCB. THIS ANALYSIS FOUND THAT CAPACITOR COMPONENTS CAUSED THE BATTERY REMOVAL TEST FAILURE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR HAD A STICKY BATTERY COMPARTMENT WHICH WOULD NOT OPEN EASILY AND THAT DURING BATTERY REPLACEMENT THE PACEMAKER SHUT DOWN IMMEDIATELY. IT WAS INDICATED THAT THIS OCCURRED WHILE IN USE ON A PATIENT WHO WAS DEPENDING ON THE PACER, SO FOLLOW-UP IS BEING CONDUCTED TO DETERMINE WHETHER THERE WAS NEGATIVE IMPACT TO THE PATIENT. THE PACER HAS BEEN RETURNED FOR SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR HAD A STICKY BATTERY COMPARTMENT WHICH WOULD NOT OPEN EASILY AND THAT DURING BATTERY REPLACEMENT THE PACEMAKER SHUT DOWN IMMEDIATELY. IT WAS INDICATED THAT THIS OCCURRED WHILE IN USE ON A PATIENT WHO WAS DEPENDING ON THE PACER, SO FOLLOW-UP IS BEING CONDUCTED TO DETERMINE WHETHER THERE WAS NEGATIVE IMPACT TO THE PATIENT. THE PACER HAS BEEN RETURNED FOR SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56444 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R