BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3860266 · Received June 10, 2014

    Report

    Report Number
    2183613-2014-00785
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 7, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Removal / Correction Number
    Z-1661-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION. PRODUCT EVENT SUMMARY: INITIAL ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT. IT WAS NOTED THAT THE MAIN CLEAR COVER WAS CONTAMINATED, THE UPPER AND LOWER CASES WERE BROKEN AND CONTAMINATED, BOTH BATTERY RELEASE LATCHES AND O-RINGS WERE CONTAMINATED, THE RING COVER AND BOTH BAIL COVERS WERE CONTAMINATED, ONE CASE SCREW WAS MISSING, THE BATTERY DRAWER AND O-RING WERE CONTAMINATED, THE MAIN PRINTED CIRCUIT BOARD (PCB) WAS OUT OF ELECTRICAL SPECIFICATION, THE MAIN KEYPAD WAS OUT OF SPECIFICATION WITH THE ON BUTTON COLLAPSED, AND THE INTERCONNECT FLEX WAS OUT OF SPECIFICATION. FURTHER ANALYSIS WAS PERFORMED ON THE MAIN PCB, INTERCONNECT FLEX AND KEYPAD ASSEMBLY. VISUAL INSPECTION NOTED NO ANOMALIES WITH THE MAIN PCB, THE INTERCONNECT FLEX TAIL THICKNESS FAILED SPECIFICATION, AND VERIFIED THAT THE ON BUTTON WAS COLLAPSED ON THE KEYPAD. BENCH TESTING NOTED THAT THE KEYPAD FAILED DUE TO COLLAPSED BUTTONS, THE ELECTRICAL FUNCTIONALITY OF THE INTERCONNECT FLEX WAS STABLE, NO ANOMALIES NOTED WITH THE MAIN PCB. CONCLUSION: COULD NOT REPRODUCE THE CUSTOMER REPORTED SHUTDOWN FAILURE, DEFECTIVE HIGH RATE FLEX CAUSED FUNCTIONAL FAILURE DUE TO COLLAPSED BUTTON, THE MAIN KEYPAD FLEX WAS OUT OF MECHANICAL SPECIFICATION DUE TO COLLAPSED BUTTON AND THE INTERCONNECT FLEX WAS OUT OF SPECIFICATION MECHANICAL.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) WOULD NOT MAINTAIN CONTINUOUS POWER AND WOULD SUDDENLY TURN OFF EVEN THOUGH THE BATTERY WAS NEW. THIS WAS DISCOVERED DURING TESTING FOR BACKUP PACING. THE EPG HAS BEEN RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342937 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1