BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2952784 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00242
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 18, 2012
    Report Date
    February 2, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER ANALYSIS WAS PERFORMED ON THE MAIN PRINTED CIRCUIT BOARD (PCB). THIS ANALYSIS NOTED THAT THE MAIN PCB FAILED TESTING DUE TO CONTAMINATION.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY (B)(4): THE GENERATOR WAS RETURNED AND ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE LIQUID CRYSTAL DISPLAY (LCD) WAS OUT OF SPECIFICATION. ANALYSIS ALSO CONFIRMED THAT THE MAIN PRINTED CIRCUIT BOARD WAS OUT OF SPECIFICATION, THE BATTERY CONTACTS WERE COMPRESSED AND ONE SIDE BAIL WAS BROKEN. (B)(4).

    Additional Manufacturer Narrative · 1

    FURTHER ANALYSIS WAS PERFORMED ON THE MAIN PRINTED CIRCUIT BOARD (PCB). THIS ANALYSIS NOTED THAT THE MAIN PCB FAILED TESTING DUE TO CONTAMINATION.

    Additional Manufacturer Narrative · 1

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

    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 BY THE BIOMEDICAL ENGINEER WAS DOING ROUTINE CHECKING OF THE EXTERNAL PULSE GENERATOR (EPG) AND FOUND IT HAD MISSING SEGMENTS IN THE LOWER DISPLAY. THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE BIOMEDICAL ENGINEER WAS DOING ROUTINE CHECKING OF THE EXTERNAL PULSE GENERATOR (EPG) AND FOUND IT HAD MISSING SEGMENTS IN THE LOWER DISPLAY. THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55688 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP RICE CREEK MFG 5388

    Patients

    Seq Age Sex Outcome Treatment
    1