BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2951678 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00061
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 19, 2012
    Report Date
    November 20, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT. IT WAS NOTED THAT THE UPPER AND LOWER CASES WERE BROKEN, THE BATTERY RELEASE WAS CONTAMINATED, TWO SIDE BAIL COVERS WERE BROKEN, THE BATTERY CONTACTS WERE COMPRESSED, THE RING WAS BENT, ONE SIDE BAIL WAS MISSING, THE BATTERY DRAWER WAS BROKEN, THE KEYBOARD PAD WAS COSMETICALLY DAMAGED AND THE MAIN PRINTED CIRCUIT BOARD (PCB) WAS OUT OF ELECTRICAL SPECIFICATION. THE PCB WAS FURTHER ANALYZED AND IT WAS FOUND THAT THE BATTERY CURRENT DRAIN WAS OUT OF SPECIFICATION DUE TO DIODE COMPONENT FAILURE. THIS TESTING VERIFIED THE BATTERY CURRENT DRAIN FAILURE, HOWEVER COULD NOT CONFIRM THE REPORTED EVENT. (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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR WAS INTERMITTENTLY PACING. THE GENERATOR WAS RETURNED FOR SERVICE. NO INDICATION WAS GIVEN AS TO PATIENT INVOLVEMENT. FOLLOW-UP HAS BEEN INITIATED TO TRY TO DETERMINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR WAS INTERMITTENTLY PACING. THE GENERATOR WAS RETURNED FOR SERVICE. NO INDICATION WAS GIVEN AS TO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56158 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1