BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2953336 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00179
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE MAIN PRINTED CIRCUIT BOARD (PCB) WAS OUT OF SPECIFICATION. IT WAS ALSO NOTED THAT THE BATTERY RELEASE, SIDE BAIL COVERS, RING COVER, HEART BLOCK, MAIN SEAL, HEART WIRE CONTACTS AND SIDE BAILS WERE CONTAMINATED, THE LEAD FLEX COVER WAS CORRODED, THE BATTERY CONTACTS WERE COMPRESSED, AND THE RING BAIL WAS BENT. FURTHER ANALYSIS WAS PERFORMED ON THE MAIN PCB. THIS ANALYSIS FOUND THAT A CAPACITOR COMPONENT ON THE PCB 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 SHUT OFF PRIOR TO THE 15-SECOND EXPECTATION WHEN THE BATTERY WAS REMOVED FOR REPLACEMENT. EVEN WHEN TESTED WITH A NEW BATTERY THE SITUATION RECURRED. THE GENERATOR HAS BEEN RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55545 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1