BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1874538 · Received October 19, 2010

    Report

    Report Number
    2649622-2010-11425
    Event Type
    Injury
    Date Received
    October 19, 2010
    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
    PA, 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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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) PERFORMANCE DATA COLLECTED FROM THE PACEMAKER DEVICE WAS ANALYZED AND SHOWED THE VENTRICULAR LEAD WAS INTERMITTENTLY OPEN BETWEEN (B)(6) 2010 AND (B)(6) 2010. THE FULL LEAD WAS RETURNED AND ANALYZED; DISTAL CONDUCTOR FRACTURED. COSMETIC CUT, COSMETIC DEPRESSION, AND A WHITE SUBSTANCE FOUND ON THE OUTER INSULATION. BLOOD PRESENT IN/ON THE HELIX MECHANISM. CORRECTED ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RV LEAD HAD A LEAD WARNING, POLARITY SWITCH, NOISE ON STORED EPISODES, LOSS OF CAPTURE AT MAXIMUM OUTPUT, AND HIGH IMPEDANCE. THE LEAD WAS WAS THOUGHT TO BE FRACTURED. THE LEAD WAS EXPLANTED AND REPLACED. NO 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 ASKU DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| ADDR01 IMPLANTABLE PULSE GENERATOR| 5076 IMPLANTABLE PACING LEAD| ADDR01 IMPLANTABLE PULSE GENERATOR