BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2810845 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15662
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    July 30, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED AND ANALYZED. THE DISTAL CONDUCTOR WAS DISTORTED. THE PROXIMAL CONDUCTOR WAS STRETCHED. THE INNER INSULATION WAS KINKED/BUCKLED AND PULLED APART (OVERSTRESS). THE INNER TUBING WAS KINKED/BUCKLED. THE HELIX/LOBE WAS DISTORTED/BENT AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. THERE WAS TISSUE ON THE HELIX AND THE LEAD WAS STRETCHED. VISUAL ANALYSIS REVEALED THE LEAD WAS DAMAGED AT IMPLANT. THE LEAD WAS RETURNED WITH THE DISTAL CONDUCTOR DISTORTED WITHIN THE CONNECTOR. THEREFORE, THE HELIX TESTS COULD NOT BE PERFORMED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT THE HELIX ON THE RIGHT ATRIAL (RA) LEAD WOULD NOT RETRACT ONCE THE LEAD WAS IN THE BODY. UPON FLUOROSCOPY, THE HELIX APPEARED TO BE EXTENDED AND BENT AT THE DISTAL TIP. THE PHYSICIAN WAS UNABLE TO EXTEND OR RETRACT THE HELIX SUCCESSFULLY. THE LEAD WAS NOT IMPLANTED AND ANOTHER LEAD WAS USED. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION THROUGHOUT THE NIGHT AND THE PHYSICIAN ATTEMPTED TO REPOSITION THE RIGHT VENTRICULAR (RV) LEAD THE FOLLOWING DAY. DURING REPOSITIONING, THE PHYSICIAN DETERMINED A LONGER LEAD WAS NEEDED IN ORDER TO ACHIEVE PLACEMENT IN AN IDEAL LOCATION OF THE HEART DUE TO THE PATIENT'S PECULIAR ANATOMY. THE RV LEAD WAS EXPLANTED AND REPLACED. NO FURTHER 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 IMPLANTABLE PACING LEAD NVN MEDTRONIC PUERTO RICO, INC. 5086MRI

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR| (B)(4) IMPLANTABLE PACING LEAD