BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3153675 · Received June 8, 2013

    Report

    Report Number
    2183613-2013-00619
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 22, 2013
    Report Date
    April 5, 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: ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE BATTERY DOOR WAS STICKING, IT WAS ATTRIBUTED TO THE UPPER CASE, BATTERY RELEASE AND BATTERY DRAWER BEING CONTAMINATED AND THE BATTERY DRAWER ALSO BEING BROKEN. ANALYSIS ALSO FOUND THE LOWER CASE BROKEN AND THE BATTERY CONTACTS COMPRESSED. (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)(6). (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 BATTERY DOOR OF THE EXTERNAL PULSE GENERATOR WOULD STICK AND WAS NOT ABLE TO BE OPENED. THE GENERATOR WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY DOOR OF THE EXTERNAL PULSE GENERATOR WOULD STICK AND WAS NOT ABLE TO BE OPENED. THE GENERATOR WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256457 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1