BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, EXTERNAL

    MDR report key: 7093242 · Received December 7, 2017

    Report

    Report Number
    3004593495-2017-00730
    Event Type
    Malfunction
    Date Received
    December 7, 2017
    Date of Event
    September 12, 2017
    Report Date
    April 10, 2018
    Manufacturer
    PLEXUS MANUFACTURING SDN. BHD
    Product Code
    DTE
    UDI-DI
    00643169230859
    PMA / PMN Number
    K150246
    Removal / Correction Number
    Z-1356-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 WAS UNABLE TO CONFIRM THE CUSTOMER COMMENT THAT THE DEVICE'S TIMING WAS NOT WORKING CORRECTLY. IT WAS NOTED THAT THERE WAS EVIDENCE OF A NON-COMPANY PERSON DISASSEMBLING AND REASSEMBLING THE DEVICE AND THAT THE OUTPUT WIRES WERE ROUTED INCORRECTLY, ALL KNOBS HAD PRY MARKS UNDER THEM, BOTH CASE HALVES WERE GOUGED (CUT), THE OUTPUT CONNECTOR WIRES (WHITE AND BLACK) WERE ROUTED INCORRECTLY AND WERE PINCHED BETWEEN THE CASE HALVES, THE KEYPAD WAS CONTAMINATED AND THE WINDOW SCRATCHED, BOTH OUTPUT CONNECTOR NUTS WERE DISCOLORED, ALL FOUR KNOBS WERE CONTAMINATED, BOTH WIRES ON THE LIQUID CRYSTAL DISPLAY WERE PINCHED BUT NOT COMPROMISED AND WIRES WERE ROUTED INCORRECTLY OVER THE BATTERY COMPARTMENT AND THE DEVICE WAS IN NEED OF THE UPDATED BATTERY SHORTING BAR DESIGN. THE ELECTRICAL AND MECHANICAL PARTS WERE INSPECTED AND ALL FOUND DEFECTIVE PARTS WERE REPLACED AND ALL OTHER IDENTIFIED ISSUES WERE RESOLVED. THE DEVICE WAS RE-CALIBRATED AND FUNCTIONALLY TESTED AND IT PASSED ITS FINAL QUALITY ASSURANCE TESTS. THIS DEVICE WAS REPORTED AS INCLUDED IN THE FIELD ACTION NOTED BUT RETURNED PRODUCT INVESTIGATION FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION. THE DEVICE IS NO LONGER INCLUDED AS PART OF THE FIELD ACTION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS ADDITIONALLY REPORTED VIA A SUBSEQUENT EMAIL FROM THE PHYSICIAN THAT WHEN THE VENTRICULAR WIRE WAS COMPLETELY UNPLUGGED FROM THE EXTERNAL PULSE GENERATOR IT WORKED FINE HOWEVER WHEN THE VENTRICULAR WIRE WAS PLUGGED IN, EVEN WITH IT "OFF" (SET TO 0 MILLIAMPERES) THE PACING MODE SWITCHED FROM ATRIAL TO JUNCTIONAL WITH AN ASSOCIATED LOSS OF ATRIAL KICK, DECREASE IN BLOOD PRESSURE AND PROMINENT VENTRICULAR WAVES ON THE RIGHT ATRIAL PRESSURE TRACING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR'S TIMING WAS NOT WORKING CORRECTLY, THAT THE P-R INTERVAL WOULD CHANGE WHEN BOTH LEADS WERE IN. IT WAS NOTED THAT THE BIOMEDICAL ENGINEER WAS UNABLE TO DUPLICATE THE ISSUE DURING PREVENTIVE MAINTENANCE. THE GENERATOR WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    871424 PULSE-GENERATOR, PACEMAKER, EXTERNAL DTE PLEXUS MANUFACTURING SDN. BHD 5392 00643169230859

    Patients

    Seq Age Sex Outcome Treatment
    1