BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX

    MDR report key: 2851941 · Received November 29, 2012

    Report

    Report Number
    2649622-2012-17479
    Event Type
    Death
    Date Received
    November 29, 2012
    Date of Event
    November 4, 2012
    Report Date
    November 4, 2012
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. ATTEMPTS FOR ADDITIONAL INFORMATION WERE UNSUCCESSFUL. HOWEVER, IF REQUESTED ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESS AND CONSIDERED ACCORDINGLY. CONCOMITANT PRODUCT: 5086 IMPLANTABLE PACING LEAD, (B)(6) 2012. (B)(4). THE LEAD HAS NOT BEEN RETURNED TO THE MANUFACTURER AND HAS NOT BEEN 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

    AN IMPLANTABLE PACING LEAD WAS REPORTED WITH NO INFORMATION. INFORMATION IDENTIFIED IN THE PAPERWORK INDICATED THAT THE PATIENT DIED APPROXIMATELY 1DAY POST IMPLANT OF THE LEAD. A CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI52

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Death RVDR01 IMPLANTABLE PULSE GENERATOR (IPG)