BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2951627 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00160
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 2, 2012
    Report Date
    January 11, 2013
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY (B)(4) THE FULL LEAD WAS RETURNED AND ANALYZED. PRIMARY ANALYSIS FINDING NOTED THAT THE LEAD CONDUCTOR WAS DISTORTED (EXTRINSIC) WITH DISTAL OVER ROTATION. THE DISTAL END/ELECTRODES WAS COVERED WITH BLOOD. VISUAL ANALYSIS NOTED THE LEAD WAS STRETCHED AND THERE WAS DAMAGE AT IMPLANT. THE LEAD WAS RECEIVED WITH STYLET IN LEAD, BLOOD ON THE HELIX AND THE HELIX PARTIALLY RETRACTED. WHEN THE HELIX WAS RETRACTED DURING THE PROCEDURE, THE IS-1 CONNECTOR PIN WAS TURNED AN EXCESSIVE NUMBER OF TIMES, RESULTING IN DISTORTION OF THE DISTAL CONDUCTOR WITH THE CONNECTOR. THIS PREVENTS THE HELIX FROM EXTENDING OR RETRACTING PROPERLY.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT CONTINUED: (B)(4) IMPLANTABLE PACING LEAD (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING FOLLOW-UP, THE RIGHT VENTRICULAR (RV) LEAD SHOWED LOW R-WAVES AND HIGH THRESHOLD. THE LEAD WAS UNABLE TO BE REPOSITIONED DUE TO A FROZEN HELIX. THE LEAD WAS REMOVED AND WAS 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
    57685 CAPSUREFIX NOVUS MRI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI58

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR (IPG)