BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2811732 · Received October 31, 2012

    Report

    Report Number
    2183613-2012-01833
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 11, 2012
    Report Date
    November 19, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE 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. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE HEART LEAD FLEX WAS OUT OF ELECTRICAL SPECIFICATION. IT WAS ALSO NOTED THAT THE LOWER CASE WAS BROKEN AND CONTAMINATED, BOTH BAIL COVERS WERE MISSING, THE RING COVER WAS MISSING, BOTH BAILS WERE MISSING, THE RING WAS MISSING AND THE KEYBOARD WAS SCRATCHED.

    Additional Manufacturer Narrative · 1

    FURTHER ANALYSIS WAS PERFORMED ON THE HEART LEAD FLEX. THIS ANALYSIS CONFIRMED THE REPORTED FAILURE, THE CAUSE WAS FOUND TO BE TWO FAILED DIODE-SUPPRESSOR COMPONENTS.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE PREVENTIVE MAINTENANCE TESTING, IT WAS DISCOVERED THAT THE EXTERNAL PULSE GENERATOR (EPG) HAD NO OUTPUTS ON EITHER THE ATRIAL OR THE VENTRICULAR SIDE. THE EPG WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE TESTING, IT WAS DISCOVERED THAT THE EXTERNAL PULSE GENERATOR HAD NO OUTPUTS ON EITHER THE ATRIAL OR THE VENTRICULAR SIDE. THE GENERATOR WAS TO BE RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE PREVENTIVE MAINTENANCE TESTING, IT WAS DISCOVERED THAT THE EXTERNAL PULSE GENERATOR (EPG) HAD NO OUTPUTS ON EITHER THE ATRIAL OR THE VENTRICULAR SIDE. THE EPG WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other