BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3071641 · Received April 22, 2013

    Report

    Report Number
    2649622-2013-05217
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    February 27, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE TREND ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS RISING. THE RV LEAD IMPEDANCES STEADILY INCREASED FROM APPROXIMATELY 450 OHMS IN (B)(4) 2012 TO APPROXIMATELY 2,800 OHMS IN (B)(4) 2013.

    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).

    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 THERE WAS INCREASING AND HIGH LEAD IMPEDANCE AND INCREASING THRESHOLDS IN THE RIGHT VENTRICULAR LEAD. SHORT V-V INTERVALS WERE ALSO INCREASING. IT WAS FURTHER REPORTED THAT THE PHYSICIAN SUSPECTED THAT THE LEAD WAS CRUSHED BY THE CLAVICLE BONE. THE LEAD WAS CAPPED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171464 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Hospitalization| R P1501DR IMPLANTABLE PULSE GENERATOR (IPG)