BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 1992640 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02964
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P980016
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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): WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. PATIENT ALERT SOUNDED FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2008. WEEKLY PACE LEAD IMPEDANCE TREND DATA SHOWS VARYING ATRIAL LEAD IMPEDANCE OF 472 TO 3824 OHMS BETWEEN (B)(6) 2009 AND (B)(6) 2010. VENTRICULAR SHORT INTERVAL COUNT=82.3 COUNTS AVG/DAY, IN 24.25 DAYS, BETWEEN (B)(6) 2010 09:49:24 AND (B)(6) 2010 15:55:46. (B)(4) THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE DEFIBRILLATION COIL WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON SEVERAL CONDUCTORS (NOT OBSTRUCTED) AND IN/ON THE HELIX MECHANISM, EXPOSED DEFIB COIL WHITE SUBSTANCE, A COSMETIC DEPRESSION AND A WHITE SUBSTANCE ON THE OUTER INSULATION, APPARENT EXPLANT DAMAGE AND THE LEAD WAS STRETCHED. (B)(4): A PARTIAL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED), THE OUTER TUBING OVERLAY WAS BREACHED CUT, THERE WAS A WHITE SUBSTANCE ON THE OUTER INSULATION, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE ATRIAL LEAD HAD HIGH IMPEDANCE, INTERMITTENT SENSING AND OVERSENSING. THE LEAD WAS TO BE ABANDONED, AND THE DEVICE REPROGRAMMED. IT WAS LATER REPORTED THAT THE ATRIAL LEAD WAS EXPLANTED AND REPLACED DUE TO HIGH THRESHOLDS. THE VENTRICULAR LEAD WAS EXPLANTED AND REPLACED DUE TO T-WAVE OVERSENSING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE ATRIAL LEAD WAS ABANDONED DUE TO HIGH IMPEDANCES AND INTERMITTENT SENSING AND SOME OVERSENSING. (B)(6) 2010, IT WAS REPORTED THAT THE PHYSICIAN PLANS TO ABANDON THE ATRIAL LEAD AND PROGRAM VVI MODE AND PROGRAMMED P-R LOGIC OFF. (B)(6) 2010. IT WAS REPORTED THAT THERE WAS T-WAVE OVERSENSING ON THE RIGHT VENTRICULAR LEAD. THE RIGHT ATRIAL LEAD HAD MEASURED HIGH THRESHOLD. BOTH LEADS WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 6940 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB