BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3990035 · Received August 7, 2014

    Report

    Report Number
    2183613-2014-01049
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    April 29, 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 CONFIRMED THE CUSTOMER COMMENT THAT THE REAR ENCLOSURE WAS DAMAGED, ITS LOWER CASE WAS BOTH BROKEN AND CONTAMINATED. ANALYSIS ALSO FOUND THAT THE UPPER CASE AND ONE SIDE BAIL COVER WERE BROKEN, THAT THE BATTERY RELEASE, BATTERY DRAWER AND BATTERY FLEX WERE CONTAMINATED, THAT ONE SIDE BAIL COVER, SIDE BAIL, RING COVER, RING BAIL AND ONE CASE SCREW WERE MISSING, THAT THE LEAD FLEX COVER WAS CORRODED, THE BOARD CONNECTOR CABLES WERE DAMAGED (COSMETIC), THE BATTERY CONTACTS WERE COMPRESSED AND CONTAMINATED, THE KEYBOARD WAS DAMAGED (COSMETIC) AND THAT THE GENERATOR NEEDED A BATTERY DRAWER O-RING. ALL DEFECTIVE PARTS WERE REPLACED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REAR ENCLOSURE ON THE EXTERNAL PULSE GENERATOR HAD SOME DAMAGE. THE GENERATOR WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT. IT WAS FURTHER REPORTED THAT THE EXTERNAL PULSE GENERATOR SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462564 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1