BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3220869 · Received July 11, 2013

    Report

    Report Number
    2649622-2013-08196
    Event Type
    Death
    Date Received
    July 11, 2013
    Date of Event
    May 21, 2013
    Report Date
    July 16, 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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ATTEMPTS FOR ADDITIONAL INFORMATION WERE UNSUCCESSFUL. HOWEVER, IF REQUESTED ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESS AND CONSIDERED ACCORDINGLY. SEDR01 IMPLANTABLE PULSE GENERATOR (IPG) IMPLANTED: 2012-(B)(6); 694765 IMPLANTABLE TACHY LEAD IMPLANTED: 2006-(B)(6), (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4). THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE AND INDICATED STRETCHING. VISUAL SUMMARY ANALYSIS OF THE LEAD WAS PERFORMED.

    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 PULSE GENERATOR (IPG) SYSTEM WAS RETURNED FROM A FUNERAL HOME WITH LITTLE INFORMATION. INFORMATION IDENTIFIED IN THEMANUFACTURE¿S DATABASE/PAPERWORK INDICATED THE PATIENT DIED APPROXIMATELY 7 MONTHS POST IMPLANT OF THE IPG SYSTEM. THE CAUSE OF DEATH WAS REPORTED AS 1) RESPIRATORY ARREST 2) SEPSIS OF UNKNOWN ORGANISMS 3) CORONARY ARTERY DISEASE AND 4) CHRONIC OBSTRUCTIVE PULMONARY DISEASE. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL RELEVANT INFORMATION REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321138 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00091 YR Death