BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3152577 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01541
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE 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. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT; HEART LEAD FLEX OUT OF SPECIFICATION (TORN SOLDER CONNECTION BY VENTRICLE CONNECTOR). ANALYSIS ALSO FOUND THE BATTERY CONTACTS COMPRESSED AND THE MAIN PRINTED CIRCUIT BOARD OUT OF ELECTRICAL SPECIFICATION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). FURTHER ANALYSIS WAS PERFORMED ON THE HEART LEAD FLEX AND MAIN PRINTED CIRCUIT BOARD (PCB). THIS ANALYSIS FOUND THAT THE HEART LEAD CONNECT FLEX ASSEMBLY WAS DEFECTIVE (OPEN CIRCUIT) AND THE FUNCTIONAL TEST FAILURE ON THE MAIN PCB WAS DUE TO A DEFECTIVE HYBRID CIRCUIT COMPONENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BLACK VENTRICLE CONNECTOR IS NOT WORKING. IT WAS ALSO REPORTED WHEN THE BIOMED WAS REPLACING THE OUTPUT CONNECTOR ON THE DEVICE, BIOMED DAMAGED THE OUTPUT BOARD. THE DEVICE WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253171 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1