BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1953034 · Received January 7, 2011

    Report

    Report Number
    2649622-2011-00023
    Event Type
    Death
    Date Received
    January 7, 2011
    Date of Event
    December 12, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    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 RESISTANCE/IMPEDANCE - PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2010 10:17:04. OVERSENSING - VENTRICULAR NST<=210 MS AVERAGE V-CYCLE ON (B)(6) 2010 IN THE TIMEFRAME BETWEEN 10:22:58 AND 10:27:30. VF<=210 MS BETWEEN (B)(6) 2010 03:30:02 AND (B)(6) 2010 03:50:16. INTERFERENCE/NOISE - VENTRICULAR SHORT INTERVAL COUNT V-SIC=15.2 COUNTS AVG/DAY, IN 26.29 DAYS, BETWEEN (B)(6) 2010 03:50:16 AND (B)(6) 2010 10:47:48.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED WHILE UNDERGOING A CRANIOTOMY UNRELATED TO THE DEVICE. THE CAUSE OF DEATH WAS NOTED TO BE A BRAIN ANEURYSM CAUSED BY A FALL. THE PATIENT HAD LAST BEEN SEEN IN THE CLINIC 2 MONTHS PREVIOUS AND HAD HOME CHECK ONE MONTH PREVIOUS AT WHICH TIMES DEVICE WORKING PROPERLY. PATIENT HAD BEEN PACEMAKER DEPENDENT. CLINIC UNSURE IF AUTOPSY PERFORMED.

    Description of Event or Problem · 1

    ASKU

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death| H