BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3170961 · Received June 14, 2013

    Report

    Report Number
    2649622-2013-08100
    Event Type
    Death
    Date Received
    June 14, 2013
    Date of Event
    May 7, 2013
    Report Date
    September 12, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPT(S) FOR ADDITIONAL INFORMATION WITH THE PHYSICIAN OFFICE WERE UNSUCCESSFUL. HOWEVER, IF REQUESTED ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESSED AND CONSIDERED ACCORDINGLY. THE DATE OF DEATH IS APPROXIMATE. PRODUCT ID: ADDRS1, IMPLANTED: (B)(6) 2013. PRODUCT ID: 5076-52, IMPLANTED: (B)(6) 2013. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY # PRODUCT ID# 5076-45 A PROXIMAL PORTION WAS RECEIVED MEASURING 7 CM. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 WAS REPORTED AS DECEASED WITH LIMITED INFORMATION THE PATIENT RECEIVED AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM APPROXIMATELY ONE WEEK PRIOR TO THE DEATH. A CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HOSPITAL'S CORONER REPORT INDICATED THE CAUSE OF DEATH AS AN ACUTE MYOCARDIAL INFARCTION. IT WAS ALSO NOTED THAT THERE WERE ATRIAL SPIKES WITH NO CAPTURE AND VENTRICULAR SPIKES WITH WIDENING QRS COMPLEX AND APPROXIMATELY TWO HOURS LATER, THE PATIENT WAS FOUND PULSELESS AND APNEIC. THE HOSPITAL ALSO INCLUDED THE PATIENT'S PAST MEDICAL HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271293 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Death