BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1922865 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-13116
    Event Type
    Injury
    Date Received
    December 13, 2010
    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
    WY, 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 FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE PROXIMAL CONDUCTOR WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THE INNER AND OUTER INSULATION WAS KINKED/BUCKLED, THE OUTER INSULATION WAS BREACHED CUT AND HAD A COSMETIC DEPRESSION, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM, THERE WAS APPARENT EXPLANT DAMAGE AND THE LEAD WAS STRETCHED. (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND THE DEFIBRILLATION COIL WAS DISTORTED AND FRACTURED. THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED) AND ON THE OUTER TUBING OVERLAY, THE INNER AND OUTER INSULATION WAS KINKED/BUCKLED, THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING (ESC) AND A DEPRESSION. THE OUTER INSULATION WAS TORN AND HAD ESC BREECH. THERE WAS BLOOD/BODY FLUID ON THE HELIX MECHANISM. (B)(4) WE ALSO RECEIVED PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. IMPEDANCE INCREASE WAS NOTED. RIGHT VENTRICULAR (RV) DEFIB AND SUPERIOR VENA CAVA (SVC) IMPEDANCE TRENDS WERE STEADY AROUND 50 OHMS UNTIL (B)(6) 2010 WHEN VALUES BEGIN TO INCREASE. IMPEDANCES WERE 110 OHMS ON (B)(6) 2010 AND 173 OHMS ON (B)(6) 2010, AND 254 OHMS ON (B)(6) 2010. DAILY HIGH VOLTAGE IMPEDANCE TRENDS SHOW RV AND SVC DEFIB IMPEDANCE FLUCTUATING BETWEEN 77 AND 254 OHMS DURING 15 DAYS PRIOR TO EXPLANT. VARYING IMPEDANCE WAS ALSO NOTED. PATIENT ALERT TIMESTAMP: (B)(6) 2010 FOR AN OUT-OF-TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE.

    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 FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE PROXIMAL CONDUCTOR WAS DISTORTED, BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), INNER INSULATION WAS KINKED/BUCKLED, OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING , BREACHED CUT AND A COSMETIC DEPRESSION, BLOOD IN/ON THE HELIX/LOBE MECHANISM, APPARENT EXPLANT DAMAGE, THE LEAD WAS STRETCHED. (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND THE DEFIBRILLATION COIL WAS DISTORTED. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), DEFIB CONDUCTOR FRACTURED DUE TO OVERSTRESS, BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY, INNER TUBING WAS KINKED/BUCKLED, OUTER TUBING WAS KINKED/BUCKLED, OUTER TUBING OVERLAY HAD COSMETIC ENVIRONMENTAL STRESS CRACKING (ESC), OUTER TUBING HAD ESC BREACH, TORN OUTER INSULATION AND COSMETIC DEPRESSION, BLOOD IN/ON HELIX. PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. IMPEDANCE INCREASE WAS NOTED. RIGHT VENTRICULAR (RV) DEFIB AND SUPERIOR VENA CAVA (SVC) IMPEDANCE TRENDS WERE STEADY AROUND 50 OHMS UNTIL (B)(6) 2010 WHEN VALUES BEGIN TO INCREASE. IMPEDANCES WERE 110 OHMS ON (B)(6) 2010 AND 173 OHMS ON (B)(6) 2010, AND 254 OHMS ON (B)(6) 2010. DAILY HIGH VOLTAGE IMPEDANCE TRENDS SHOW RV AND SVC DEFIB IMPEDANCE FLUCTUATING BETWEEN 77 AND 254 OHMS DURING 15 DAYS PRIOR TO EXPLANT. VARYING IMPEDANCE WAS ALSO NOTED. PATIENT ALERT TIME STAMP: (B)(6) 2010 FOR AN OUT-OF-TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE.

    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 FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE PROXIMAL CONDUCTOR WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THE INNER AND OUTER INSULATION WAS KINKED/BUCKLED, THE OUTER INSULATION WAS BREACHED CUT AND HAD A COSMETIC DEPRESSION, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM, THERE WAS APPARENT EXPLANT DAMAGE AND THE LEAD WAS STRETCHED. (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND THE DEFIBRILLATION COIL WAS DISTORTED AND FRACTURED. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED) AND ON THE OUTER TUBING OVERLAY, THE INNER AND OUTER INSULATION WAS KINKED/BUCKLED, THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING (ESC) AND A DEPRESSION. THE OUTER INSULATION WAS TORN AND HAD ESC BREECH. THERE WAS BLOOD/BODY FLUID ON THE HELIX MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTRICULAR LEAD HAD AN INCREASE IN IMPEDANCE TO A HIGH VALUE. IT WAS ALSO REPORTED THAT THE LEAD WAS FRACTURED DUE TO A SUSPECTED CLAVICLE RIB CRUSH. THE VENTRICULAR LEAD WAS EXPLANTED AND REPLACED. IT WAS FURTHER REPORTED THAT THE ATRIAL LEAD DISLODGED DURING THE EXPLANT PROCEDURE OF THE VENTRICULAR LEAD. THE ATRIAL LEAD WAS ALSO EXPLANTED 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 NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB