BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT

    MDR report key: 2945845 · Received February 6, 2013

    Report

    Report Number
    2649622-2013-00075
    Event Type
    Death
    Date Received
    February 6, 2013
    Date of Event
    September 27, 2012
    Report Date
    January 9, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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. ATTEMPT(S) FOR ADDITIONAL INFORMATION WERE UNSUCCESSFUL. HOWEVER, IF REQUESTED ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESSED AND CONSIDERED ACCORDINGLY. CONCOMITANT PRODUCT: 5076 IMPLANTABLE PACING LEAD 2003 (B)(6). (B)(4). THE LEAD WAS NOT RETURNED TO THE MANUFACTURER AND WILL NOT BE EVALUATED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A PATIENT WITH AN IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) SYSTEM WAS REPORTED AS DECEASED VIA A SOCIAL MEDIA NETWORK WITH NO FURTHER INFORMATION. INFORMATION IDENTIFIED IN THE MANUFACTURE'S DATA BASE INDICATED THE PATIENT DIED APPROXIMATELY THREE YEARS POST IMPLANT OF THE IPG SYSTEM. A CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50978 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694358V

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Death (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR