BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2951803 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00239
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    October 31, 2012
    Report Date
    November 7, 2012
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. CONCOMITANT MEDICAL DEVICE: RVDR01 IMPLANTABLE PULSE GENERATOR, IMPLANTED: (B)(6) 2012. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES FOUND. IT WAS NOTED THAT THE DISTAL ELECTRODE WAS COVERED WITH BODY TISSUE/FIBROTIC GROWTH. THE OUTER INSULATION WAS CUT AND A VISUAL SUMMARY INDICATED APPARENT EXPLANT DAMAGE. THE ANALYST COMMENTED THAT THE LEAD WAS RECEIVED PARTIALLY RETRACTED WITH BODY TISSUE/FIBROTIC MATERIAL ON THE HELIX. HELIX WAS CLEANED IN PREPARATION FOR HELIX EXTENSION/RETRACTION AND LENGTH TESTING. EXTENSION/RETRACTION AND LENGTH TESTING WERE PERFORMED AND ALL RESULTS, INCLUDING ELECTRICAL TESTING, WERE WITHIN SPECIFIED PARAMETERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A WEEK POST IMPLANT, THE PATIENT WAS EXPERIENCING CHEST DISCOMFORT AND PAIN WITH INSPIRATION AND WHEN SITTING FORWARD. AN ECHOCARDIOGRAM SHOWED RIGHT VENTRICULAR LEAD PERFORATION AND A SMALL EFFUSION. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT IS ENROLLED IN THE (B)(6). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56362 CAPSUREFIX NOVUS MRI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI52

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Hospitalization| R (B)(4) IMPLANTABLE PACING LEAD