BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2952235 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00093
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 13, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003/S70
    Removal / Correction Number
    Z-1661-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(6). (B)(4).

    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

    FURTHER ANALYSIS WAS LATER PERFORMED ON THE MAIN PCB. THE PCB WAS INSTALLED IN AN ENGINEERING DEVICE, THE RATE WAS CHECKED AT 30 PPM, THEN SLOWLY INCREASED TO 180 BPM, NO SUDDEN CHANGES IN THE RATE WERE OBSERVED, RATE WAS CHECKED AT 180 BPM, MEASURED IN SPECIFICATION. THE RESISTANCE WAS MEASURED BETWEEN THE INTERCONNECT FLEX AND MAIN PCB, GOOD CONTACT RESISTANCE WAS MEASURED. CONCLUSION: NO DEFECT FOUND.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT. THE MAIN PRINTED CIRCUIT BOARD (PCB) WAS FOUND TO BE ELECTRICALLY OUT OF SPECIFICATION AND CONTAMINATED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR REGISTERED HIGH PACES-PER-MINUTE ON ALL SETTINGS. THE GENERATOR WAS RETURNED FOR REPAIR. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR REGISTERED HIGH PACES-PER-MINUTE ON ALL SETTINGS. THE GENERATOR WAS RETURNED FOR REPAIR. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55834 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1