BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2022644 · Received March 17, 2011

    Report

    Report Number
    2649622-2011-04103
    Event Type
    Death
    Date Received
    March 17, 2011
    Date of Event
    February 9, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. 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. A LEAD INTEGRITY ALERT (LIA) THAT OCCURRED ON (B)(6) 2011 DUE TO THE NON-SUSTAINED VENTRICULAR TACHYCARDIA AND VENTRICULAR-SENSING INTEGRITY COUNTER (V-SIC) CONDITIONS BEING MET FOR LIA. THE TECH SERVICES ANALYSIS OF THIS CONDITION WAS THAT THERE MAY HAVE BEEN AN AGONAL RHYTHM THAT CONTRIBUTED TO THE V-SIC AND SENSING PATTERN AND THAT THE PATIENT "MAY HAVE ALREADY BEEN NEAR DEATH OR IN THE DYING PROCESS". MULTIPLE SHORT VENTRICLE TO VENTRICLE SENSED EVENTS OF < 220 MS ARE OBSERVED ON THE (B)(6) 2011. (3 EPISODES NON-SUSTAINED TACHYCARDIA, 3 EPISODES VENTRICULAR FIBRILLATION, 5 EPISODES"LFP" (LEAD FAILURE PREDICTOR) V-SIC COUNTS INCREASE ARE 65.7 AVG/DAY BEGINNING (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD DIED. DEVICE INTERROGATION FOLLOWING THE PATIENT DEATH REVEALED THAT A LEAD INTEGRITY ALERT WAS TRIGGERED ON THE DAY OF DEATH. THE POST MORTEM DID NOT REVEAL CAUSE OF DEATH.

    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. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death