BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1960774 · Received January 14, 2011

    Report

    Report Number
    2649622-2011-00056
    Event Type
    Death
    Date Received
    January 14, 2011
    Date of Event
    November 12, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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) 2010. OF NOTE, THE REPORTABLE MALFUNCTION IS NORMALLY SUBMITTED VIA A BIMONTHLY MEDWATCH REPORT SUBMISSION THAT WOULD HAVE BEEN DUE ON (B)(6) 2011 . INFORMATION WAS SUBSEQUENTLY RECEIVED ON (B)(6) 2011 AND REVEALED 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. EVALUATION SUMMARY (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. RESISTANCE/IMPEDANCE INCREASE - WEEKLY MEASUREMENT DATA SHOWS A GRADUAL INCREASE FOR MIN AND MAX RV PACE=656 TO 1024 OHMS PEAK BETWEEN (B)(6) 2010 AND (B)(6) 2010. PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2010 02:15:03.

    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) 2010. OF NOTE, THE REPORTABLE MALFUNCTION IS NORMALLY SUBMITTED VIA A BIMONTHLY MEDWATCH REPORT SUBMISSION THAT WOULD HAVE BEEN DUE ON (B)(4) 2011 . INFORMATION WAS SUBSEQUENTLY RECEIVED ON (B)(4) 2011 AND REVEALED 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.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RV (RIGHT VENTRICULAR) PACING IMPEDANCE HAD STEADILY INCREASED OVER THE PREVIOUS 9 MONTHS. LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT HAD DIED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RV (RIGHT VENTRICULAR) PACING IMPEDANCE HAD STEADILY INCREASED OVER THE PREVIOUS 9 MONTHS. LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT HAD DIED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. FOLLOW UP WITH CLINIC REVEALED THE PATIENT WENT TO HOSPICE, THE DEVICE THERAPIES WERE TURNED OFF, AND THE PATIENT DIED THAT SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death