BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2922721 · Received January 18, 2013

    Report

    Report Number
    2649622-2013-00043
    Event Type
    Death
    Date Received
    January 18, 2013
    Date of Event
    November 23, 2012
    Report Date
    January 22, 2013
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE 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. ATTEMPT(S) FOR ADDITIONAL INFORMATION WERE UNSUCCESSFUL. HOWEVER, IF REQUESTED ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESSED AND CONSIDERED ACCORDINGLY. CONCOMITANT PRODUCTS: 6947 IMPLANTABLE DEFIBRILLATION LEAD 2012 (B)(6); 5076 IMPLANTABLE PACING LEAD 2012 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AN IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) SYSTEM WAS RETURNED FROM AN UNKNOWN SOURCE WITH NO INFORMATION. INFORMATION IDENTIFIED IN THE MANUFACTURE'S DATA BASE INDICATED THE PATIENT DIED LESS THAN A YEAR POST IMPLANT OF THE LEADS. A CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    AN IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) SYSTEM WAS RETURNED FROM AN UNKNOWN SOURCE WITH NO INFORMATION. INFORMATION IDENTIFIED IN THE MANUFACTURE'S DATA BASE INDICATED THE PATIENT DIED LESS THAN A YEAR POST IMPLANT OF THE LEADS. A CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28298 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419488

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Death (B)(4) IMPLANTABLE CARDIO-VERTER DEFIBRILLATOR