BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3151969 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-05578
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    March 8, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. P1501DR IMPLANTABLE PULSE GENERATOR 2005-07-01 5076-45 IMPLANTABLE PACING LEAD (B)(6) 2005; 5068-45 IMPLANTABLE PACING LEAD (B)(6) 1998; 5034-52 IMPLANTABLE PACING LEAD (B)(6) 1998. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DISTAL PORTION OF THE LEAD WAS RETURNED, ANALYZED AND THE OUTER INSULATION OF THE LEAD DEVELOPED A COSMETIC DEPRESSION AND BREACH DUE TO A DEPRESSION WHILE IN VIVO. THE ANALYST COMMENTED, THE OUTER INSULATION BREACHED/DEPRESSION/IN-VIVO WAS FOUND. THIS IS NOT RELATED TO THE COMPLAINT.

    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 PRESENTED WITH SEVERE TRICUSPID REGURGITATION. THE PHYSICIAN FELT IT WAS FROM THE RIGHT VENTRICULAR LEAD IMPLANTED IN 2005. THE LEAD WAS EXPLANTED AND NOT REPLACED. THE PHYSICIAN IMPLANTED A NEW SINGLE CHAMBER DEVICE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253305 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Hospitalization| R