BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2954880 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-02417
    Event Type
    Death
    Date Received
    February 11, 2013
    Date of Event
    November 24, 2012
    Report Date
    November 24, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    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. THE INITIAL REPORTED EVENT WAS RECEIVED ON (B)(6) 2012. OF NOTE, THE SERIOUS INJURY IS NORMALLY SUBMITTED VIA A BIMONTHLY MEDWATCH REPORT SUBMISSION THAT WOULD HAVE BEEN DUE ON (B)(6) 2012. INFORMATION WAS SUBSEQUENTLY RECEIVED ON (B)(6) 2013 AND REVEALED THE PATIENT DIED. AS THERE IS NEW INFORMATION THAT REASONABLY SUGGESTS THE DEVICE HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH, THIS EVENT NO LONGER QUALIFIES FOR BIMONTHLY REPORTING AND IS THEREFORE BEING SUBMITTED AS A 30-DAY REPORT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. A CAUSE OF DEATH WAS REQUESTED AND WILL NOT BE RECEIVED. CONCOMITANT PRODUCT: 5076 IMPLANTABLE PACING LEAD (B)(6) 2007. (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

    IT WAS REPORTED THE PATIENT IS DECEASED. TWO DAYS PRIOR TO DEATH THE PATIENT WAS BROUGHT TO THE EMERGENCY ROOM (ER) BY AMBULANCE WITH A 'DIMINISHED' LEVEL OF CONSCIOUSNESS (LOC) AND A HEART RATE IN THE TWENTIES. INTERROGATION OF THE DEVICE SHOWED THE RIGHT VENTRICULAR (RV) LEAD HAD AN IMPEDANCE OF GREATER THAN NINE THOUSAND, NINE HUNDRED AND NINETY-NINE OHMS; THERE WAS NO RV CAPTURE OR SENSING. THE PATIENT REFUSED FURTHER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58405 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00089 YR Death| H| L VEDR01 IMPLANTABLE PULSE GENERATOR