BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2812807 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16472
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    August 23, 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
    AR, 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, ANALYZED AND THERE WAS TISSUE ON THE HELIX. IT WAS NOTED THAT THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. IT WAS VISUALLY NOTED THAT THE LEAD WAS RETURNED WITH TISSUE ON THE HELIX AND THE HELIX WAS NOT COMPLETELY RETRACTED. HOWEVER, THE HELIX FUNCTIONS WERE ABLE TO BE EXTENDED AND RETRACTED WITHIN SPECIFICATION AFTER THE TISSUE WAS REMOVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD UNSTABLE THRESHOLD SINCE IMPLANT. UNDER FLUOROSCOPY, THE LEAD WAS STILL ATTACHED TO THE SEPTAL WALL, HOWEVER ONCE REMOVED FROM THE BODY THERE WAS A SUBSTANTIAL AMOUNT OF TISSUE INTERTWINED IN THE HELIX WHICH HAD NOT COMPLETELY RETRACTED. THE LEAD WAS REMOVED AND REPLACED WITH A DIFFERENT LEAD. THERE WERE NO PATIENT COMPLICATIONS 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 65 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR| (B)(4) IMPLANTABLE PACING LEAD