BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3990083 · Received August 7, 2014

    Report

    Report Number
    2183613-2014-01051
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    April 9, 2014
    Report Date
    June 5, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS DETERMINED THAT THE UPPER AND LOWER CASES WERE CONTAMINATED AND BROKEN, THAT THE BATTERY RELEASE, TWO SIDE BAIL COVERS, THE LEAD FLEX COVER AND THE BATTERY DRAWER WERE CONTAMINATED, THAT THE RING COVER WAS BROKEN, THE ATRIAL OUTPUT CONNECTOR WAS DAMAGED, THE BATTERY CONTACTS COMPRESSED AND ONE SIDE BAIL AND THE RING WERE BENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR ORIGINALLY RETURNED AS A TRADE-IN DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465246 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1