BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2791565 · Received October 15, 2012

    Report

    Report Number
    2183613-2012-01732
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003/S70
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND 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. EVALUATION SUMMARY: (B)(4): ANALYSIS FOUND THAT THE LOWER CASE WAS BROKEN AND THE MAIN PRINTED CIRCUIT BOARD (PCB) WAS OUT OF SPECIFICATION.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4): ANALYSIS FOUND THAT THE LOWER CASE WAS BROKEN AND THE MAIN PRINTED CIRCUIT BOARD (PCB) WAS OUT OF SPECIFICATION. FURTHER ANALYSIS WAS PERFORMED ON THE PCB. THIS PCB WAS BELIEVED TO HAVE BEEN EXPERIENCING MULTIPLE FAILURE MODES, PRIMARILY DUE TO A FAILED INTEGRATED CIRCUIT COMPONENT. TYPICAL FAULT ISOLATION PROCEDURES WERE FOLLOWED WITH ATYPICAL RESULT. CONSISTENCY BETWEEN TEST RESULTS WAS NOT ACHIEVED, ALTHOUGH FAILURE SIMILARITY WAS NOTED. THE NECESSITY TO REPLACE A HIGH NUMBER OF COMPONENTS DURING FAULT ISOLATION WAS BELIEVED TO HAVE DEGRADED PCB FUNCTION. ANALYSIS WAS HALTED AFTER A TEST EQUIPMENT FAILURE, WHICH CAUSED CATASTROPHIC PCBA DAMAGE. IT WAS NOT POSSIBLE TO COMPLETE FAULT ISOLATION AND VERIFY THE COMPONENT FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR WAS RETURNED FOR REPAIR. PER FOLLOW UP, NO ADDITIONAL INFORMATION IS AVAILABLE. THE UNIT WAS FOUND IN THE BIOMEDICAL DEPARTMENT OF THE HOSPITAL AND NO PATIENT INVOLVEMENT WAS INDICATED. THE DEVICE WAS ANALYZED AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1 Other