BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2203346 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-12328
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 PRIMARY ANALYSIS REVEALED THAT THE OUTER INSULATION WAS BREACHED (CLAVICLE-RIB CRUSH). THERE WAS BLOOD/BODY FLUID PRESENT ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED). THE OUTER INSULATION WAS BREACHED CUT AND HAD A COSMETIC DEPRESSION. IT WAS ALSO NOTED THAT THE HELIX/LOBE WAS DISTORTED/BENT.

    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 PRIMARY ANALYSIS REVEALED THAT THE OUTER INSULATION WAS BREACHED (CLAVICLE-RIB CRUSH). THERE WAS BLOOD/BODY FLUID PRESENT ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED). THE OUTER INSULATION WAS BREACHED CUT AND HAD A COSMETIC DEPRESSION. IT WAS ALSO NOTED THAT THE HELIX/LOBE WAS DISTORTED/BENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD THRESHOLDS INCREASED SINCE IMPLANT AND "FIBROTIC INGROWTH" WAS NOTED ON THE HELIX. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR| 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR| 5076 IMPLANTABLE PACING LEAD