BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3991667 · Received August 8, 2014

    Report

    Report Number
    2183613-2014-00980
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 26, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Removal / Correction Number
    Z-1661-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION.  BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT BE DETERMINED THAT THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO HOSPITAL FOR COMPLETE HEART BLOCK AND THE TEMPORARY PACEMAKER WAS CONNECTED. THE NURSING STAFF NOTED THE PACEMAKER WAS SENSITIVE AND LOSS OF CAPTURE OCCURED WITH PATIENT MOVEMENT. THE DEVICE REMAINED IN USE AND CONTINUED TO CAPTURE AS LONG AS THE PATIENT DID NOT MOVE. THE NEXT DAY THE NURSING STAFF NOTED MULTIPLE PACER SPIKES ON THE 5-LEAD STRIP AND THE PATIENT REPORTED NOT FEELING WELL; PULSE RATE WAS 80 BPM AND CHEST X-RAY WAS ORDERED TO VERIFY WIRE PLACEMENT. LATER, THE PATIENT REPORTED THEY FELT WORSE. THE STRIP SHOWED MULTIPLE PACER SPIKES WITH NO CAPTURE AND LONG PAUSES, AND THE INTERNIST ATTEMPTED TO MAKE CHANGES TO THE PACEMAKER SETTINGS. DURING THE CHEST X-RAY THE PACER STARTED PACING AND CAPTURING AND THE PATIENT STATED THEY WERE STARTING TO FEEL BETTER. AFTER X-RAY THE PACEMAKER FAILED TO CAPTURE AND THE STRIP SHOWED NUMEROUS PACEMAKER SPIKES AND THE PATIENT LOST CONSCIOUSNESS, RESPIRATION BECAME AGONAL. THE PACEMAKER WIRE WAS ADJUSTED AND GOOD CAPTURE WAS OBTAINED. A SECO ND X-RAY WAS DONE AND DURING THAT TIME THE PACEMAKER AGAIN FAILED TO CAPTURE. THE PATIENT THEN WENT ASYSTOLE AND NO CAPTURE WAS PRESENT FOR A FEW SECONDS OFF AND ON. THE PATIENT WAS INTERMITTENTLY PACED TRANSCUTENEOUSLY. THE PATIENT WENT UNRESPONSIVE, A CODE WAS CALLED AND CPR WAS COMMENCED. THE TRANSVENOUS PACEMAKER WAS TURNED 'OFF' AND TRANSCUTENOUS PACING COMMENCED. FURTHER ADJUSTMENTS WERE MADE TO TRANSVENOUS SETTINGS AND ONCE THE PATIENT WAS CONSCIOUS TRANSVENOUS PACING WAS RECOMMENCED WITH GOOD CAPTURE. IT IS EXPECTED THAT THE TEMPORARY PACEMAKER WILL BE RETURNED TO THE MANUFACTURER. THE PACING EQUIPMENT WAS CHANGED AND NO FURTHER ISSUESWERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472695 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R