BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2963517 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-02194
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    February 9, 2012
    Report Date
    March 12, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS FOUND: (B)(4) FULL LEAD NO ANOMALIES FOUND, THERE WAS BLOOD ON THE DISTAL CONDUCTOR, THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING (ESC). PRODUCT ID 6947 IMPLANTABLE TACHY LEAD IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT ID (B)(4) IMPLANTABLE PACING LEAD IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2012, PRODUCT ID (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)  IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD INTEGRITY ALERT TRIPPED DUE TO NON-SUSTAINED TACHYCARDIA (NST) EPISODES WITH NOISE AND OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD. THE RV SENSING TREND SHOWED A DECREASE IN R-WAVES AROUND THE SAME TIME THAT THE LEAD WAS IMPLANTED SIX WEEKS PRIOR, AND NOW THE LEAD WAS NOT CAPTURING EVEN AT MAXIMUM OUTPUT. THE LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT LEAD HAD NO CAPTURE AND SMALL R-WAVES; HOWEVER THE LEAD REMAINED IN USE. A FEW DAYS LATER, THE IMPLANTED SYSTEM (DEVICE AND LEADS) WAS REMOVED DUE TO TWIDDLER'S SYNDROME. THERE WERE NO PLANS TO REIMPLANT THE SYSTEM. THE DEVICE AND LEADS HAVE BEEN RETURNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS REMOVED DUE TO TWIDDLER'S SYNDROME. THERE WERE NO PLANS TO REIMPLANT THE LEAD. THE LEAD HAS BEEN RETURNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67514 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Hospitalization| R 4194 PACING LEAD