BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2842824 · Received November 21, 2012

    Report

    Report Number
    2649622-2012-17467
    Event Type
    Death
    Date Received
    November 21, 2012
    Date of Event
    December 1, 2009
    Report Date
    January 14, 2013
    Manufacturer
    MPRI
    Product Code
    LWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #THE DEVICE(S) ASSOCIATED WITH THIS ADVERSE OUTCOME WAS/WERE RETURNED FROM AN UNKNOWN SOURCE WITH NO INFORMATION. CONSEQUENTLY, CONTACT INFORMATION TO COMPLETE FOLLOW-UP IS NOT REASONABLY KNOWN. THEREFORE, ATTEMPTS FOR ADDITIONAL INFORMATION CANNOT BE MADE. EVALUATION SUMMARY: LFG039586V THE PROXIMAL SECTION OF THE LEAD WAS RETURNED, ANALYZED AND ANALYSIS RESULTS REVEALED NO ANOMALIES FOUND. IT WAS FURTHER NOTED THAT BLOOD WAS PRESENT ON THE COIL (NOT OBSTRUCTIVE) THE PROXIMAL CONDUCTOR WAS DISTORTED, INNER AND OUTER INSULATION WAS BREACHED AND EXPLANT DAMAGE IS OBSERVED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE(S) ASSOCIATED WITH THIS ADVERSE OUTCOME WAS/WERE RETURNED FROM AN UNKNOWN SOURCE WITH NO INFORMATION. CONSEQUENTLY, CONTACT INFORMATION TO COMPLETE FOLLOW-UP IS NOT REASONABLY KNOWN. THEREFORE, ATTEMPTS FOR ADDITIONAL INFORMATION CANNOT BE MADE. (B)(4) 5076 IMPLANTABLE PACING LEAD X2. (B)(4).

    Description of Event or Problem · 1

    THE SYSTEM WAS RETURNED WITH NO INFORMATION. A DATABASE SEARCH BY SERIAL NUMBER SHOWED THE PATIENT EXPIRED LESS THAN 1 YEAR AFTER IMPLANT. THE DEATH OCCURRED GREAT THAN 2 YEARS AGO. NO COMPLAINTS, ALLEGATIONS, OR, PREVIOUS CONTACTS, REGARDING THE SYSTEM OR ANY INDIVIDUAL COMPONENTS HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    THE SYSTEM WAS RETURNED WITH NO INFORMATION. A DATABASE SEARCH BY SERIAL NUMBER SHOWED THE PATIENT EXPIRED LESS THAN 1 YEAR AFTER IMPLANT. THE DEATH OCCURRED GREAT THAN 2 YEARS AGO. NO COMPLAINTS, ALLEGATIONS, OR, PREVIOUS CONTACTS, REGARDING THE SYSTEM OR ANY INDIVIDUAL COMPONENTS HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419488

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Death C154DWK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR