BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3991173 · Received August 8, 2014

    Report

    Report Number
    2183613-2014-00998
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    April 26, 2014
    Report Date
    June 2, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    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).

    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 COULD NOT CONFIRM THE REPORTED EVENT, THE DEVICE PASSED FUNCTIONAL AND BENCH TESTING WITH NO ANOMALIES FOUND. IT WAS NOTED THAT THE UPPER AND LOWER CASES WERE BROKEN, THE BATTERY RELEASE WAS CONTAMINATED, ONE BAIL COVER WAS BROKEN, THE BATTERY CONTACTS WERE COMPRESSED, THE RING WAS BENT, THE BATTERY DRAWER WAS BROKEN AND THE KEYBOARD WAS SCRATCHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE EXTERNAL PULSE GENERATOR WAS CONNECTED TO A PATIENT, THE PATIENT'S HEART RATE DROPPED TO 30 BPM. QUICK INSPECTION SHOWED THE PACEMAKER APPEARED TO BE FUNCTIONING CORRECTLY. THE PATIENT WAS CHANGED TO A BACK UP PACEMAKER AND CAPTURE WAS REGAINED WITH SAME SETTINGS. IT WAS ALLEGED THAT THERE WAS A POSSIBLE PACEMAKER MALFUNCTION AND IT WAS RETURNED FOR TESTING. THE PATIENT'S LEVEL OF CONSCIOUSNESS DID NOT CHANGE BUT THE PATIENT DID COMPLAIN OF LIGHT-HEADEDNESS. THE EPG HAS BEEN RETURNED FOR REPAIR. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467645 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention