BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2790825 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15373
    Event Type
    Injury
    Date Received
    October 15, 2012
    Report Date
    November 29, 2012
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE PROXIMAL CONDUCTOR WAS FRACTURED, THE PROXIMAL CONDUCTOR WAS DISTORTED, ALL CONDUCTORS WERE STRETCHED, THERE WAS BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR (NOTOBSTRUCTED), THE INNER INSULATION WAS KINKED/BUCKLED, THE INNER TUBING WAS KINKED/BUCKLED, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THERE WAS APPARENT EXPLANT DAMAGE AND THE LEAD WAS STRETCHED. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) THE PARTIAL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE PROXIMAL CONDUCTOR WAS DISTORTED, THE PROXIMAL CONDUCTOR WAS CUT, ALL CONDUCTORS WERE STRETCHED, THERE WAS BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), THE INNER INSULATION WAS KINKED/BUCKLED, THE INNER TUBING WAS KINKED/BUCKLED, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THERE WAS APPARENT EXPLANT DAMAGE AND THE LEAD WAS STRETCHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON DEVICE INTERROGATION, IT WAS NOTED THAT THE RIGHT VENTRICLE (RV) LEAD IMPEDANCE WAS HIGH AND THRESHOLD WAS UNSTABLE. THE LEAD WAS EXAMINED UNDER FLUOROSCOPY AND THE HELIX MECHANISM WAS NOT EXTENDED ON THE RV LEAD OR ATRIAL LEAD. DURING THE REVISION THE RV LEAD IT WAS NOTED THAT THE LEAD "WAS GROWN TOGETHER" WITH THE ATRIAL LEAD WHICH RESULTED INTO A DISLODGMENT OF THE ATRIAL LEAD AND DIFFICULTY IN EXTRACTION. IT WAS ALSO REPORTED THAT THE ATRIAL LEAD WAS DEFECTIVE AT THE INSULATION OF THE SUTURE-SLEEVE. THE RV LEAD AND THE ATRIAL LEAD WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON DEVICE INTERROGATION, IT WAS NOTED THAT THE RIGHT VENTRICLE (RV) LEAD IMPEDANCE WAS HIGH AND THRESHOLD WAS UNSTABLE. THE LEAD WAS EXAMINED UNDER FLUOROSCOPY AND THE HELIX MECHANISM WAS NOT EXTENDED ON THE RV LEAD OR ATRIAL LEAD. DURING THE REVISION THE RV LEAD IT WAS NOTED THAT THE LEAD "WAS GROWN TOGETHER" WITH THE ATRIAL LEAD WHICH RESULTED INTO A DISLODGMENT OF THE ATRIAL LEAD AND DIFFICULTY IN EXTRACTION. IT WAS ALSO REPORTED THAT THE ATRIAL LEAD WAS DEFECTIVE AT THE INSULATION OF THE SUTURE-SLEEVE. THE RV LEAD AND THE ATRIAL LEAD WERE 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
    1 CAPSUREFIX NOVUS MRI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Hospitalization| R EMDR01 IMPLANTABLE PULSE GENERATOR