BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS LEAD

    MDR report key: 2121182 · Received June 13, 2011

    Report

    Report Number
    2649622-2011-07795
    Event Type
    Injury
    Date Received
    June 13, 2011
    Report Date
    April 21, 2020
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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) DETAILED ANALYSIS OF THE DEVICE WAS NOT PERFORMED AT THIS TIME DUE TO PENDING LITIGATION. THEREFORE, WE ARE UNABLE TO FULLY EVALUATE THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PROXIMAL PORTION OF THE LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. VISUAL ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. 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 WAS TAKEN TO THE EMERGENCY ROOM AFTER RECEIVING INAPPROPRIATE THERAPY DUE TO OVERSENSING, UNDERSENSING, AND VARYING IMPEDANCE ON THE RIGHT VENTRICULAR PACE/SENSE PORTION OF THE LEAD. THE LEAD WAS EXTRACTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP NOVUS LEAD ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4092 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R 6949 IMPLANTABLE TACHY LEAD| 4068 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB