BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2291073 · Received October 13, 2011

    Report

    Report Number
    2649622-2011-15371
    Event Type
    Injury
    Date Received
    October 13, 2011
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. PROGRAMMER DATA SHOWS A LEAD INTEGRITY ALERT ON (B)(4)-2011 17:26:17. ONE - PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(4)-2011 17:26:17. TEN - VENTRICULAR NST <=210 MS BETWEEN (B)(4)-2011 14:14:57 AND (B)(4)-2011 22:29:08.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY : THE PARTIAL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED; ANALYSIS REVEALED A BREACH DUE TO A DEPRESSION ON THE OUTER INSULATION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIZZINESS AND LIGHTHEADEDNESS. THE LEAD INTEGRITY ALERT (LIA) TRIGGERED, AND THE ATRIAL AND VENTRICULAR LEADS EXHIBITED OVERSENSING AND NOISE WITH A MIRROR IMAGE ELECTROGRAM (EGM). IT WAS THOUGHT THAT THE CAUSE OF THE NOISE WAS THE LEADS MOVING IN OPPOSITE DIRECTION RELATIVE TO EACH OTHER. THE LEADS WERE REPROGRAMMED AND REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT DURING A ROUTINE DEVICE UPGRADE PROCEDURE, THE PHYSICIAN NOTED POSSIBLE RIGHT ATRIAL LEAD DYSFUNCTION - ALTHOUGH THERE WERE NO ANOMALIES DURING PRE-OPERATIVE ANALYSIS - AND ELECTED TO EXPLANT AND REPLACE THE LEAD AS THE REST OF THE SYSTEM WAS BEING REMOVED BECAUSE OF LEAD ADHESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R 6949 IMPLANTABLE TACHY LEAD