BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3151676 · Received June 7, 2013

    Report

    Report Number
    2183613-2013-00573
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 27, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE GENERATOR WAS RETURNED AND ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE UNIT HAD NO POWER, THIS WAS ATTRIBUTED TO ONE BATTERY CONTACT NOT BEING FULLY SEATED, AND IT WAS REPLACED. ANALYSIS ALSO FOUND THE UPPER CASE AND ONE BAIL COVER BROKEN, THE LOWER CASE, UPPER CASE, BATTERY RELEASE AND LEAD FLEX COVER CONTAMINATED, THE BATTERY RELEASE SPRING BENT, THE LEAD FLEX O-RING AND THE BATTERY DRAWER O-RING MISSING, THE KEYBOARD SCRATCHED AND THE SERIAL NUMBER LABEL DAMAGED. (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 THE EXTERNAL PULSE GENERATOR HAD NO POWER, EVEN WITH A NEW BATTERY. THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR HAD NO POWER, EVEN WITH A NEW BATTERY. THE GENERATOR WAS 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
    252388 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1