BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX

    MDR report key: 1802624 · Received August 17, 2010

    Report

    Report Number
    2649622-2010-08848
    Event Type
    Death
    Date Received
    August 17, 2010
    Date of Event
    May 13, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P980016
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. 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. HIGH VENTRICULAR IMPEDANCE/RESIST. THE VENTRICULAR PACE IMPEDANCE MEASUREMENT WAS IN THE 300 - 400 OHM RANGE UNTIL THE WEEK ENDING (B)(6) 2008 WHEN FOR THE NEXT SEVEN WEEKS THE MAX VALUE WAS INFINITE. THE LAST WEEK MAX VALUE WAS 3856 OHMS. INTERFERENCE/NOISE. THE LIFETIME VENTRICULAR SENSING INTEGRITY COUNT IS 172,563 AND ALL BUT TWO COUNTS OCCURRED SINCE (B)(6) 2008. A HIGH VALUE OF THIS COUNT CAN INDICATE A POSSIBLE INTERMITTENCY IN THE SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS OVERSENSING, A POSSIBLE RV (RIGHT VENTRICULAR) LEAD FRACTURE, HIGH IMPEDANCE GREATER THAN 3000 OHMS, AND THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS. BOTH THE RV AND ATRIAL LEADS WERE CAPPED. IT WAS LATER DETERMINED VIA REVIEW OF MANUFACTURER'S DATABASE THAT THE PATIENT HAD DIED 3 MONTHS LATER. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 6940 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death 7278 IMPLANTABLE PACEMAKER/CARDIO/DEFIB