BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3151984 · Received June 7, 2013

    Report

    Report Number
    2183613-2013-00538
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE CURSOR WOULD NOT ALLOW ALL MODES TO BE SELECTED AND IT WAS ATTRIBUTED TO THE ENCODER FLEX BEING OUT OF SPECIFICATION ELECTRICALLY. ANALYSIS ALSO FOUND THE UPPER CASE BROKEN AND DENTED, AFFECTING THE KEYBOARD FIT, SO IT WAS REPLACED, BOTH BAIL COVERS WERE BROKEN, TWO HEART WIRE CONTACTS WERE DISCOLORED, THE RING WAS BENT AND THE KEYBOARD WAS SCRATCHED AND DAMAGED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE CHECK OF THE EXTERNAL PULSE GENERATOR IT WAS NOTED THAT WHILE SOME MODES COULD BE SELECTED, OTHER MODES WERE UNAVAILABLE FOR SELECTION. THE GENERATOR WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE CHECK OF THE EXTERNAL PULSE GENERATOR IT WAS NOTED THAT WHILE SOME MODES COULD BE SELECTED,OTHER MODES WERE UNAVAILABLE FOR SELECTION. THE GENERATOR WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253318 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1