BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3990824 · Received August 8, 2014

    Report

    Report Number
    2183613-2014-01025
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    April 1, 2014
    Report Date
    May 29, 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: DURING ANALYSIS IT WAS DETERMINED THAT THE RING COVER AND BATTERY DRAWER WERE BROKEN, THE BATTERY CONTACTS WERE COMPRESSED, ONE BAIL WAS BENT, THE LIQUID CRYSTAL DISPLAY WAS "BLEEDING" AND THE BATTERY DRAWER NEEDED AN O-RING. (B)(4).

    Description of Event or Problem · 1

    THE EXTERNAL PULSE GENERATOR WHICH WAS RETURNED AS A TRADE-IN/EXCHANGE FOR A NEW MODEL 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
    470576 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1