BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENE

    MDR report key: 2812201 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03806
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    June 5, 2012
    Report Date
    November 30, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S1
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    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. VENTRICULAR NON-SUSTAINED TACHYCARDIA EPISODES OF LESS THAN OR EQUAL TO 210 MS WERE NOTED FROM (B)(6) 2012. THERE WERE VENTRICULAR FIBRILLATION EPISODES OF 180 MS OR LESS AVERAGE V-CYCLE ON (B)(6) 2012. LEAD FAILURE PREDICTOR HIGH RATE NON-SUSTAINED OF 207 MS OR LESS AVERAGE V-CYCLE ON (B)(6) 2012. VENTRICULAR SHORT INTERVAL COUNT V-SIC=5248 COUNTS, IN 115.87 DAYS, BETWEEN (B)(6) 2012. THERE WAS A PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(6) 2012.

    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 RECEIVED INAPPROPRIATE SHOCKS DUE TO NOISE AND OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD. IT WAS NOTED THAT THERE WAS ELECTRICAL MAGNETIC INTERFERENCE (EMI) FROM AN UNGROUNDED SOURCE CAUSING THE DEVICE TO DELIVER THE SHOCKS. THE DEVICE AND LEAD REMAIN 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 TRANSVENE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 6936

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Life Threatening| O