BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2951823 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00065
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 28, 2012
    Report Date
    November 28, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003/S072
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE MAIN PRINTED CIRCUIT BOARD (PCB) WAS OUT OF SPECIFICATION. IT WAS ALSO NOTED THAT THE UPPER AND LOWER CASES WERE BROKEN, THE BATTERY RELEASE AND BATTERY DRAWER WERE CONTAMINATED, THE BATTERY CONTACTS WERE COMPRESSED, THE RING WAS BENT AND THE KEYBOARD PAD WAS COSMETICALLY DAMAGED. (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'S (EPG) WOULD NOT CONTINUE TO PACE FOR A MINIMUM OF FIFTEEN SECONDS WHEN THE BATTERY WAS REMOVED. THE EPG SHUT OFF WHEN THE BATTERY WAS REMOVED. IT WAS FURTHER REPORTED WHILE USED ON A PATIENT, THE BATTERY NEEDED TO BE CHANGED AND THE DEVICE WENT BLANK. THE EPG WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR'S (EPG) WOULD NOT CONTINUE TO PACE FOR A MINIMUM OF FIFTEEN SECONDS WHEN THE BATTERY WAS REMOVED. THE EPG SHUT OFF WHEN THE BATTERY WAS REMOVED. IT WAS FURTHER REPORTED WHILE USED ON A PATIENT, THE BATTERY NEEDED TO BE CHANGED AND THE DEVICE WENT BLANK. THE EPG WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57642 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention