BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1982160 · Received February 9, 2011

    Report

    Report Number
    2649622-2011-00205
    Event Type
    Death
    Date Received
    February 9, 2011
    Date of Event
    January 18, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    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

    EVALUATION SUMMARY: (B)(4): PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND WAS ANALYZED. THE ANALYSIS REVEALED HIGH RESISTANCE/IMPEDANCE. THERE WAS ONE PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2010 15:00:32. WEEKLY HIGH VOLTAGE LEAD IMPEDANCE TREND DATA SHOWS AN ABRUPT SPIKE INCREASE FOR MAX DEFIBRILLATION ACTIVE CAN ON IMPEDANCE EQUAL TO 90 TO 254 OHMS MAX BETWEEN (B)(6) 2010 AND (B)(6) 2010, THEN RETURNS TO BASELINE AT 59 OHMS ON (B)(6) 2010. OVERSENSING WAS ALSO OBSERVED. ONE VENTRICULAR NON SUSTAINED TACHYCARDIA EPISODE WAS SEEN (B)(6) 2011 00:07:02. THERE WERE THREE VENTRICULAR FIBRILLATION EPISODE. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED APPROXIMATELY TEN WEEKS POST IMPLANT OF THE IMPLANTABLE CARDIAC DEFIBRILLATOR AND RIGHT ATRIAL PACING LEAD. THERE WAS A REVISION OF A COMPETITOR HIGH VOLTAGE LEAD ONE WEEK LATER. DURING THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE. AN ECHOCARDIOGRAM WAS PERFORMED AND NO EFFUSION WAS OBSERVED. IT WAS ALSO NOTED AND THE PATIENT HAD SMALL R-WAVES. THE PATIENT DID RECOVER. THE PATIENT HAD A DEVICE CHECK PERFORMED SIX WEEKS LATER AND DURING DEFIBRILLATION THRESHOLD TEST THE PATIENT CONTINUED TO HAVE SMALL R-WAVES, HOWEVER WAS ABLE TO BE RESCUED. A CARE-ALERT WENT THROUGH TO THE ELECTROPHYSIOLOGY LAB ON THE DAY OF DEATH. ATTEMPTS TO REACH THE PATIENT WERE UNSUCCESSFUL. THE PATIENT WAS FOUND DEAD AT HOME. VIA THE CARE-ALERT READINGS THE PATIENT HAD SMALL R-WAVES PRIOR TO DEATH, WAS IN VENTRICULAR FIBRILLATION, SHOCKED APPROPRIATELY, BUT COULD NOT BE RESCUED. CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    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 60 YR Death 7122 COMPETITOR IMPLANTABLE TACHY LEAD| 7122 COMPETITOR IMPLANTABLE TACHY LEAD