BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE FIX NOVUS

    MDR report key: 3160280 · Received June 10, 2013

    Report

    Report Number
    2649622-2013-07958
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE HELIX OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO PULLING/STRETCHING/OVERSTRESS. ALSO VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT AND LEAD STRETCHING. THE ANALYST COMMENTED THAT THE LEAD WAS RETURNED WITHTHE HELIX STRETCHED. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DISLODGED DURING IMPLANT. THE PHYSICIAN ATTEMPTED TO REPOSITION THE LEAD BUT IT BECAME LODGED IN THE SUPERIOR VENA CAVA (SVC) AND WAS ULTIMATELY EXPLANTED AND REPLACED WITH A NEW RV LEAD. UPON EXTRACTION IT WAS NOTED THAT THE HELIX HAD BECOME NOTICEABLY UNCOILED AND HAD RETAINED SOME TISSUE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259630 CAPSURE FIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00089 YR