BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3072599 · Received April 23, 2013

    Report

    Report Number
    2649622-2013-05312
    Event Type
    Death
    Date Received
    April 23, 2013
    Date of Event
    January 14, 2013
    Report Date
    April 23, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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)(4) 2013. OF NOTE, THE SERIOUS INJURY OF INFECTION IS NORMALLY SUBMITTED VIA AN ALTERNATIVE SUMMARY REPORT SUBMISSION THAT WOULD HAVE BEEN DUE ON 2013-04-30. INFORMATION WAS SUBSEQUENTLY RECEIVED ON (B)(4) 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. THIS IS ONE OF THREE PRODUCTS CAPTURING THE INFECTION AND DEATH OF THIS PATIENT. A REPLACEMENT DEVICE WAS IMPLANTED AND WAS ACTIVE AT THE TIME OF THE PATIENT'S DEATH AND THE DEATH IS ALSO BEING REPORTED ON THAT DEVICE. (B)(4). CONCOMITANT PRODUCTS: ADDRS1 IMPLANTABLE PULSE GENERATOR (IPG) IMPLANTED: (B)(6) 2012; 5076-45 IMPLANTABLE PACING LEAD IMPLANTED: (B)(6) 2006.

    Additional Manufacturer Narrative · 1

    A REPLACEMENT DEVICE WAS IMPLANTED AND WAS ACTIVE AT THE TIME OF THE PATIENT'S DEATH AND THE DEATH IS ALSO BEING REPORTED ON THAT DEVICE. THIS IS CAPTURED IN REGULATORY REPORT NUMBER: 3004209178-2013-06736.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFECTION OCCURRED. THE IMPLANTABLE PULSE GENERATOR SYSTEM WAS EXPLANTED AND REPLACED. FURTHER REVIEW OF THE MANUFACTURER'S DATABASE INDICATED THE PATIENT IS DECEASED AND DIED APPROXIMATELY ONE WEEK AFTER THE REPLACEMENT SYSTEM WAS IMPLANTED. ADDITIONAL INFORMATION OBTAINED INDICATED THE PATIENT PRESENTED WITH PAIN AT THE DEVICE SITE, REDNESS IN THE AREA AS WELL AS DEVICE EXPOSURE AND SITE DRAINAGE. THE ORGANISM WAS IDENTIFIED AS (B)(6). THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON INTRAVENOUS ANTIBIOTICS VIA A PERIPHERALLY INSERTED CENTRAL CATHETER AND DIED THE DAY AFTER DISCHARGE. THE CAUSE OF DEATH HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFECTION OCCURRED. THE IMPLANTABLE PULSE GENERATOR SYSTEM WAS EXPLANTED AND REPLACED. FURTHER REVIEW OF THE MANUFACTURER'S DATABASE INDICATED THE PATIENT IS DECEASED AND DIED APPROXIMATELY ONE WEEK AFTER THE REPLACEMENT SYSTEM WAS IMPLANTED. ADDITIONAL INFORMATION OBTAINED INDICATED THE PATIENT PRESENTED WITH PAIN AT THE DEVICE SITE, REDNESS IN THE AREA AS WELL AS DEVICE EXPOSURE AND SITE DRAINAGE. THE ORGANISM WAS IDENTIFIED AS (B)(6). THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON INTRAVENOUS ANTIBIOTICS VIA A PERIPHERALLY INSERTED CENTRAL CATHETER AND DIED THE DAY AFTER DISCHARGE. THE CAUSE OF DEATH HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173629 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Death| H| R