BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3993160 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09454
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: D154AWG ICD, IMPLANTED: (B)(6) 2008. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY - A PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. THE DISTAL SEGMENT WAS RECEIVED IN BAD CONDITION; EXPLANT DAMAGE AND ANALYZED. THE PROXIMAL CONDUCTOR OF THE LEAD BECAME EXTRINSICALLY FRACTURED DUE TO MELTING. THE OUTER INSULATION OF THE LEAD DEVELOPED A BREACH DUE TO A DEPRESSION WHILE IN VIVO. THE OUTER INSULATION OF THE LEAD DEVELOPED A COSMETIC DEPRESSION WHILE IN VIVO. THE OUTER INSULATION OF THE LEAD WAS OBSERVED TO HAVE BLOOD INGRESSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD WAS OVERSENSING AND CAUSING MISTAKEN IDENTIFICATION OF THE ATRIAL FIBRILLATION. THE LEAD WAS EX PLANTED 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
    472476 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Hospitalization| R 6947 LEAD