BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 4162937 · Received October 10, 2014

    Report

    Report Number
    2183613-2014-01260
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    June 9, 2014
    Report Date
    August 4, 2014
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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 CONFIRMED THE CUSTOMER COMMENT OF A DAMAGED FRONT CASE, THE LIQUID CRYSTAL DISPLAY LENS WAS FOUND TO BE CRACKED. ANALYSIS ALSO FOUND THE UPPER AND LOWER CASES BROKEN, THE KEYBOARD DAMAGED AND THAT THE DEVICE NEEDED A BATTERY DRAWER O-RING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR HAD A DAMAGED FRONT CASE (ITS MAIN PLASTIC COVER WAS CRACKED). THE GENERATOR WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT. IT WAS FURTHER REPORTED THAT THE GENERATOR SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639245 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1