BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO DR

    MDR report key: 1925208 · Received December 14, 2010

    Report

    Report Number
    6000144-2010-06240
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    September 1, 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
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    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 PATIENT WENT TO THE ER DUE TO SHOCKS AND THAT EVALUATION INDICATED THAT T WAVE OVERSENSING HAD LEAD TO THE INAPPROPRIATE SHOCKS. IT WAS FURTHER REPORTED THAT A PATIENT ALERT HAD TRIGGERED FOR RIGHT VENTRICULAR IMPEDANCE OF 1007 OHMS. IT WAS LATER REPORTED THAT THE LEAD WAS CAPPED AND REPLACED AND 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 PATIENT WENT TO THE ER DUE TO SHOCKS AND THAT EVALUATION INDICATED THAT T WAVE OVERSENSING HAD LEAD TO THE INAPPROPRIATE SHOCKS. IT WAS FURTHER REPORTED THAT A PATIENT ALERT HAD TRIGGERED FOR RIGHT VENTRICULAR IMPEDANCE OF 1007 OHMS. THE DEVICE AND LEAD REMAINS IN USE. 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 VIRTUOSO DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D154AWG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD