BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA DR

    MDR report key: 2811302 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06309
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    June 4, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    Z-2120-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4) - THE FULL LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. HOWEVER, THE PROXIMAL CONDUCTOR WAS STRETCHED AND HAD BLOOD/BODY FLUID (NOT OBSTRUCTED). THE OUTER INSULATION WAS MELTED AND WAS BREACHED CUT. THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. THERE WAS TISSUE ON THE HELIX. THE LEAD WAS STRETCHED AND THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD HAD INCREASED THRESHOLD. THE LEAD WAS EXTRACTED. DURING THE LEAD REPLACEMENT, THE PACEMAKER WAS TAKEN OUT OF POCKET. THE VENTRICULAR LEAD WAS DISCONNECTED TO CHECK THRESHOLD. WHEN THE VENTRICULAR LEAD WAS REINSERTED. THE PACEMAKER WENT TO A UNIPOLAR CONFIGURATION AND CEASED TO PACE. THE DEVICE WAS THEN EXPLANTED AND REPLACED AND THE VENTRICULAR LEAD RECONNECTED. THE DEVICE PERFORMED APPROPRIATELY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. VEDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R 4076 IMPLANTABLE PACING LEAD