BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE Z

    MDR report key: 1930748 · Received December 16, 2010

    Report

    Report Number
    2649622-2010-15327
    Event Type
    Death
    Date Received
    December 16, 2010
    Date of Event
    January 19, 2009
    Report Date
    February 25, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S33
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. AT THE TIME OF THE RETRO REVIEW, IT WAS NOTED IN THE MANUFACTURER'S DATABASE THAT THE PATIENT HAD DIED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE ATRIAL LEAD HAD IMPEDANCE OF 109 OHMS BIPOLAR AND CAPTURE THRESHOLD WERE 4 VOLTS WITH NO CAPTURE IN UNIPOLAR POLARITY. INSULATION BREACH WAS SUSPECTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT HAD EXPIRED. FOLLOW UP REPORTED DEVICE CHECK (B)(6) 2008 SHOWED ATRIAL LEAD WARNING WITH LOW IMPEDANCE IN BIPOLAR. REPROGRAMMING HAD BEEN TRIED, BUT PATIENT WOULD NOT TOLERATE UNIPOLAR. SCHEDULED TO FOLLOW UP IN ONE MONTH. IN (B)(6) 2009, CARDIOLOGIST QUESTIONING PACEMAKER MALFUNCTION AND TOLD "TOP LEAD NOT WORKING." THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE Z IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5034 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Required Intervention| D