BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2952250 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00148
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LWP
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY EVALUATION SUMMARY (B)(4): THE GENERATOR WAS RETURNED AND ANALYSIS CONFIRMED THE CUSTOMER COMMENTS THAT THE UPPER AND LOWER CASES WERE BROKEN AND THAT THE BATTERY WAS NOT EJECTING DUE TO THE BATTERY RELEASE. ANALYSIS ALSO FOUND THAT THE LOWER CASE AND BATTERY DRAWER WERE CONTAMINATED (STICKY), THAT THE SIDE BAIL COVERS, RING COVER, SIDE BAILS AND RING WERE MISSING, THE LEAD FLEX COVER AND BATTERY DRAWER O-RING WERE CONTAMINATED, TWO CASE SCREWS AND THE RING COVER SCREW WERE MISSING, THE LIQUID CRYSTAL DISPLAY (LCD) WAS MISSING SEGMENTS AND THE BATTERY CONTACTS WERE COMPRESSED. (B)(4).

    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)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CASING STANDOFFS WERE BROKEN INTERNALLY ON THE EXTERNAL PULSE GENERATOR, CAUSING THE CASE TO NOT ALIGN PROPERLY. IT WAS FURTHER NOTED THAT THE BATTERY WAS NOT EJECTING. THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CASING STANDOFFS WERE BROKEN INTERNALLY ON THE EXTERNAL PULSE GENERATOR, CAUSING THE CASE TO NOT ALIGN PROPERLY. IT WAS FURTHER NOTED THAT THE BATTERY WAS NOT EJECTING. THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55924 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP RICE CREEK MANUFACTURING 5388

    Patients

    Seq Age Sex Outcome Treatment
    1