BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3152072 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-05552
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    March 12, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. (B)(4), PRODUCT ID P1501DR PACEMAKER (B)(4), IMPLANTED: (B)(6) 2006; 5076-52 IMPLANTABLE PACING IMPLANTABLE PACING LEAD (B)(6) 2006.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    EVENT SUMMARY- THE FULL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED. THE DISTAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS EARLY BATTERY DEPLETION. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR LEAD SHOWED LEAD IMPEDANCES GREATER THAN 3000 OHMS AND THERE WAS NOISE. THE DEVICE WAS EXPLANTED AND REPLACED. THE LEAD WAS 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
    252926 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Hospitalization| R