BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO VR

    MDR report key: 1925635 · Received December 14, 2010

    Report

    Report Number
    6000144-2010-06334
    Event Type
    Injury
    Date Received
    December 14, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S062
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 DEVICE WAS ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4) ANALYSIS OF THE LEAD 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): THE DEVICE WAS ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. ANALYSIS RESULTS REVEALED THAT THE OUTER TUBING OVERLAY WAS MELTED. BLOOD/BODY FLUID WAS PRESENT ON THE OUTER TUBING OVERLAY. ALL CONDUCTORS WERE NOTED TO BE DISTORTED. THE INNER TUBING WAS KINKED/BUCKLED. THERE WAS AN OUTER INSULATION COSMETIC DEPRESSION. THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULATION ON THE PACE/SENSE PORTION OF THE LEAD HAD PEELED BACK NEXT TO THE DEVICE HEADER, THERE WAS HIGH THRESHOLD, AN APPARANT LEAD FRACTURE, AND NO CAPTURE. THE LEAD WAS CAPPED AND REPLACED. IT WAS REPORTED THAT THE DEVICE HAD NO PACING OUTPUT. THE DEVICE WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULATION ON THE PACE/SENSE PORTION OF THE LEAD HAD PEELED BACK NEXT TO THE DEVICE HEADER, THERE WAS HIGH THRESHOLD, AN APPARENT LEAD FRACTURE, AND NO CAPTURE. PART OF THE LEAD WAS REMOVED AND THE REMAINDER OF THE LEAD WAS CAPPED. THE LEAD WAS REPLACED. IT WAS REPORTED THAT THE DEVICE HAD NO PACING OUTPUT. THE DEVICE WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIRTUOSO VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D154VWC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R