BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA DR

    MDR report key: 1802848 · Received August 17, 2010

    Report

    Report Number
    6000144-2010-04211
    Event Type
    Injury
    Date Received
    August 17, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    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.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEADS HAD BEEN IMPLANTED IN THE WRONG PORTS. ATRIAL CAPTURE WAS NOTED WITH THE VENTRICULAR LEAD, AND VENTRICULAR CAPTURE NOTED WITH THE ATRIAL LEAD. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED EROSION. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEADS HAD BEEN IMPLANTED IN THE WRONG PORTS. ATRIAL CAPTURE WAS NOTED WITH THE VENTRICULAR LEAD, AND VENTRICULAR CAPTURE NOTED WITH THE ATRIAL LEAD. THE DEVICE REMAINS IN USE. 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 ASKU NVZ MEDTRONIC MED REL, INC. VEDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| O| R 1388T COMPETITOR IMPLANTABLE PACING LEAD| 5068 IMPLANTABLE PACING LEAD| 5068 IMPLANTABLE PACING LEAD| 1388T COMPETITOR IMPLANTABLE PACING LEAD