BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2952927 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00163
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY (B)(4): THE GENERATOR WAS RETURNED AND ANALYSIS COULD NOT CONFIRM THE CUSTOMER COMMENT THAT THE UNIT HAD INTERMITTENT OUTPUT WHILE PACING. ANALYSIS DID CONFIRM THE CUSTOMER COMMENT THAT THE UPPER AND LOWER CASES WERE BROKEN. ANALYSIS ALSO FOUND THE UPPER AND LOWER CASES, BATTERY RELEASE, HEART BLOCK, LEAD FLEX COVER, HEART WIRE CONTACTS AND KEYBOARD PAD CONTAMINATED, THE RING COVER AND TWO SIDE BAIL COVERS BROKEN, THE BATTERY CONTACTS COMPRESSED, THE RING BENT, ONE SIDE BAIL MISSING AND THE BATTERY DRAWER OUT OF SPECIFICATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR HAD INTERMITTENT OUTPUT WHILE PACING AND MULTIPLE CRACKS IN ITS CASE. THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR HAD INTERMITTENT OUTPUT WHILE PACING AND MULTIPLE CRACKS IN ITS CASE. THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56029 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1