BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENE

    MDR report key: 2953105 · Received February 9, 2013

    Report

    Report Number
    6000023-2013-00004
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    February 26, 2013
    Manufacturer
    MEDTRONIC, B.V.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. OVERSENSING WAS NOTED. THERE WERE 15 VENTRICULAR NON-SUSTAINED TACHYCARDIA EPISODES <(><<)>=190 MS BETWEEN (B)(6) 2009 AND (B)(6) 2011. THERE WERE 2 VENTRICULAR FIBRILLATION (VF) EPISODES <(><<)>=120 MS AVERAGE VENTRICULAR-CYCLE ON (B)(6) 2009 AND (B)(6) 2011. A LEAD INTEGRITY ALERT TRIGGERED. THE PROGRAMMER DATA SHOWS 1 - PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(6) 2011. THERE WAS 1 - PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD DELIVERED AN INAPPROPRIATE SHOCK, HAD RISING THRESHOLDS OVER TIME AND NOISE WAS DETECTED ON THE RIGHT VENTRICULAR CHANNEL. THE LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT THRESHOLD VALUE INCREASED OVER TIME. THE PATIENT RECEIVED INAPPROPRIATE SHOCKS ON (B)(6) 2011. NOISE WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55627 TRANSVENE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, B.V. 693665X

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Hospitalization| L| R