BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3160326 · Received June 10, 2013

    Report

    Report Number
    2183613-2013-00782
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    February 27, 2012
    Report Date
    April 2, 2013
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED PRODUCT EVENT SUMMARY: THE UNIT WAS MECHANICALLY INTACT. IT WAS CLEANED AND INSPECTED. UNIT TESTED AUTOMATED TEST SYSTEM, PASSED, NO ANOMALIES FOUND.

    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. PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT. HOWEVER, THE PATIENT CONNECTOR WAS FOUND TO BE LOOSE, WHICH LIKELY CAUSED THE REPORTED RATE ISSUE. THE BATTERY CONTACTS WERE ALSO OBSERVED TO BE CONTAMINATED, AND THE UPPER AND LOWER CASES DAMAGED/BROKEN. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT, THE DEVICE PASSED FUNCTIONAL AND BENCH TESTING. IT WAS NOTED THAT THE SERIAL NUMBER LABEL WAS LOOSE IN THE BATTERY COMPARTMENT, THE MAIN PRINTED CIRCUIT BOARD (PCB) SCREW HAD WORN AWAY THE CIRCUIT TRACE TO THE TOP OF THE BOARD, NEAR THE HEART LEAD FLEX, THE MAIN PCB AND BATTERY FLEX WERE CORRODED, THE HEART LEAD FLEX WAS CONTAMINATED, THE RING COVER WAS BROKEN, THE MAIN CLEAR COVER WAS MISSING, THE HEART LEAD FLEX WAS MAKING CONTACT HOWEVER THE INSERTION ALIGNMENT WITH THE CONNECTOR WAS POOR, THE INTERCONNECT FLEX SCREWS WERE PAINTED AND HAD WORN INTO THE INTERCONNECT FLEX BOARD NOT AFFECTING ANY CIRCUIT TRACES, THE SILICONE IS ON ONLY ONE SIDE OF THE POTENTIOMETERS, THE INTERCONNECT FLEX BETWEEN THE POTENTIOMETERS WAS NOT ROUTED PROPERLY, AND THE BATTERY RETURNED MEASURED 8.12 VOLTS, THE BATTERY WAS REPLACED AS A PREVENTATIVE. FURTHER ANALYSIS WAS PERFORMED ON THE FLEX. THIS EXAMINATION OF THE FLEX SOLDER PADS REVEALED TWO SETS OF CONTACT AREAS WITH THE PINS, INDICATING THAT THE FLEX HAD LIKELY BEEN INSERTED TWICE INTO THE CONNECTOR. THE OLDER OF THE TWO CONTACT AREAS SHOWED HEAVY FRETTING CORROSION WHEREAS THE NEWER CONTACT AREAS SHOWED FRETTING BUT ONLY MINOR CORROSION. THE SURFACE ALSO REVEALED A MODERATE AMOUNT OF LEAD CARBONATE ON THE FLEX SOLDER PADS AWAY FROM THE CONTACT AREAS.

    Additional Manufacturer Narrative · 1

    A FIELD CORRECTIVE ACTION WAS INITIATED FOR THIS DEVICE. THE UNIT WAS AGAIN RETURNED FOR FURTHER ANALYSIS, AT THE REQUEST OF THE MANUFACTURER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    APPROXIMATELY 6 WEEKS AGO, A FIELD CORRECTIVE ACTION WAS INITIATED FOR THE SUSPECT MEDICAL DEVICE NOTED IN SECTION D WHICH MAY INVOLVE INTERMITTENT PERFORMANCE OF CERTAIN PACING FUNCTIONS.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE EXTERNAL PULSE GENERATOR (EPG) WAS IN USE WITH A PATIENT DURING CARDIAC SURGERY FOR AN AORTIC DISSECTION, THE EPG STIMULATED AT A RATE OTHER THAN WHAT WAS PROGRAMMED. THE PATIENT EXPERIENCED TACHYCARDIA AND A DROP IN ATRIAL BLOOD PRESSURE. OF NOTE, THE EPG WAS SET IN "SENTINEL" (NOT ASYNCHRONOUSLY) MODE. THE EPG WAS TURNED OFF. THE PATIENT HAD TO BE DEFIBRILLATED EXTERNALLY AND THEN RESUSCITATED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE EXTERNAL PULSE GENERATOR WAS PACING THE PATIENT AT A RATE OF 180 BEATS PER MINUTE (BPM) INSTEAD OF THE 40 - 50 BPM THAT IT HAD BEEN SET TO. THE PATIENT HAD TO BE DEFIBRILLATED, REANIMATED, AND RESUSCITATED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE EXTERNAL PULSE GENERATOR WAS RETURNED AGAIN, AT THE REQUEST OF THE MANUFACTURER, TO DO ADDITIONAL ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259777 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R