BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA DR

    MDR report key: 2790085 · Received October 15, 2012

    Report

    Report Number
    6000144-2012-05399
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    August 7, 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 ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE PROXIMAL CONDUCTOR WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), THE OUTER INSULATION HAD A COSMETIC CUT, THE OUTER INSULATION WAS BREACHED CUT, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COMPLAINED OF SHORTNESS OF BREATH WHILE WALKING. IT WAS ALSO REPORTED THAT PRIOR TO THIS COMPLAINT THE DAY AFTER THE IMPLANT PROCEDURE THE RIGHT VENTRICULAR (RV) LEAD HAD NO CAPTURE, HIGH IMPEDANCE, SMALL R WAVES AND HIGH THRESHOLDS. THE RV LEAD WAS REPOSITIONED AND IT WAS CONCLUDED THAT A MICRO PERFORATION OCCURRED. AFTER THE COMPLAINT OF SHORTNESS OF BREATH ANOTHER REVISION WAS ATTEMPTED. DUE TO THE UNCERTAINTY OF THE LAST REVISION AND THE SENSING ISSUE BOTH THE RV LEAD AND DEVICE WERE EXPLANTED AND REPLACED. WHEN THE RV LEAD WAS EXAMINED OUT OF THE BODY, THE TIP OF THE LEAD WAS MUCH STIFFER THAN USUAL. NO FURTHER 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 86 YR Hospitalization| L| R 4076 IMPLANTABLE PACING LEAD