BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2952285 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00090
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 30, 2012
    Report Date
    December 3, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    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

    (B)(4)

    Additional Manufacturer Narrative · 1

    EVALULATION SUMMARY (B)(4): THE GENERATOR WAS RETURNED AND ANALYSIS COULD NOT CONFIRM THE CUSTOMER COMMENT THAT THE BATTERY DRAWER WOULD NOT STAY CLOSED, THOUGH IT DID CONFIRM THE COMMENT THAT THE FASTENER WAS BROKEN. ANALYSIS FOUND THAT THE UPPER AND LOWER CASES, BOTH BAIL COVERS AND THE BATTERY DRAWER WERE BROKEN AND THAT THE KEYBOARD WAS SCRATCHED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY DRAWER OF THE EXTERNAL PULSE GENERATOR (EPG) WOULD NOT STAY CLOSED. THE "FASTENER IS BROKEN." THE EPG WAS SUBSEQUENTLY RETURNED FOR REPAIR, WITH ADDITIONAL INFORMATION STATING THAT THE BATTERY COULD NOT BE REMOVED, THE FRONT CASE WAS BROKEN, AND IT MAY HAVE BEEN DROPPED. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY DRAWER OF THE EXTERNAL PULSE GENERATOR (EPG) WOULD NOT STAY CLOSED. THE "FASTENER IS BROKEN." THE EPG WAS SUBSEQUENTLY RETURNED FOR REPAIR, WITH ADDITIONAL INFORMATION STATING THAT THE BATTERY COULD NOT BE REMOVED, THE FRONT CASE WAS BROKEN, AND IT MAY HAVE BEEN DROPPED. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY DRAWER OF THE EXTERNAL PULSE GENERATOR (EPG) WOULD NOT STAY CLOSED. THE "FASTENER IS BROKEN." THE EPG WAS SUBSEQUENTLY RETURNED FOR REPAIR, WITH ADDITIONAL INFORMATION STATING THAT THE BATTERY COULD NOT BE REMOVED, THE FRONT CASE WAS BROKEN, AND IT MAY HAVE BEEN DROPPED. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56261 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1