BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3278980 · Received August 10, 2013

    Report

    Report Number
    2649622-2013-10455
    Event Type
    Injury
    Date Received
    August 10, 2013
    Report Date
    August 29, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. CONTINUATION: PRODUCT ID 6945-65 IMPLANTABLE TACHY LEAD IMPLANTED: 2000-(B)(6), PRODUCT ID D274DRG IMPLANTABLE CARDIOVERTER DE FIBRILLATOR (ICD) IMPLANTED: 2010-(B)(6), PRODUCT ID 5076-52 IMPLANTABLE PACING LEAD IMPLANTED: 2000-(B)(6), (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED. THE DISTAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS REVEALED IMPEDANCE ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE AND A LEAD IMPEDANCE OUT OF RANGE ALERT. ANALYSIS OF THE DEVICE MEMORY ALSO INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER). THERE WAS 14 NON-SUSTAINED TACHYCARDIA (NST) AND 1 VENTRICULAR FIBRILLATION (VF) EPISODES OF LESS THAN 220 MS V-V CYCLE ARE RECORDED ON (B)(6) 2013. 195 VENTRICULAR SIC OCCUR SINCE (B)(6) 2013. AN OUT-OF-TOLERANCE (OOT) SUBTHRESHOLD LEAD IMPEDANCE ALERT WAS RECORDED ON (B)(6) 2013.

    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 RECEIVED MULTIPLE INAPPROPRIATE SHOCKS DUE TO OVERSENSING NOISE FROM FRACTURED PACE/SENSE PORTION OF THE RIGHT VENTRICULAR (RV) LEAD. IT WAS NOTED LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382511 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Hospitalization| L| R