BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3990202 · Received August 7, 2014

    Report

    Report Number
    2183613-2014-01047
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    March 20, 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 OF CASE DAMAGE, BOTH THE UPPER AND LOWER CASES ARE BROKEN. ANALYSIS ALSO FOUND THAT THE BATTERY RELEASE, LEAD FLEX COVER AND BATTERY DRAWER WERE CONTAMINATED, ONE SIDE BAIL COVER WAS BROKEN, THE RING COVER AND RING BAIL WERE MISSING, THE BATTERY CONTACTS WERE COMPRESSED AND THE KEYBOARD WAS SCRATCHED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) HAD CASE DAMAGE. THE EPG WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT. IT WAS FURTHER REPORTED THAT THE GENERATOR 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
    464499 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1