BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3990729 · Received August 8, 2014

    Report

    Report Number
    2183613-2014-01028
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 30, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE CUSTOMER COMMENT THAT THE GENERATOR DID NOT PACE FOR THE EXPECTED AMOUNT OF TIME FOLLOWING BATTERY REPLACEMENT, THE GENERATOR PASSED VISUAL INSPECTION AND ALL INCOMING FUNCTIONAL TESTS. (B)(4).

    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).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING REMOVAL OF THE BATTERY THE EXTERNAL PULSE GENERATOR DID NOT CONTINUE TO PACE FOR THE EXPECTED AMOUNT OF TIME. THE GENERATOR WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING REMOVAL OF THE BATTERY THE EXTERNAL PULSE GENERATOR DID NOT CONTINUE TO PACE FOR THE EXPECTED AMOUNT OF TIME. THE GENERATOR WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468556 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1