BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENE

    MDR report key: 1863120 · Received October 9, 2010

    Report

    Report Number
    2182208-2010-00767
    Event Type
    Injury
    Date Received
    October 9, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S1
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 PATIENT HAD A HIGH SENSING INTEGRITY COUNT (SIC) SINCE APRIL WITH ONLY ONE NON-SUSTAINED TACHYCARDIA (NST) WITH NO SHORT INTERVALS STORED. LAST APRIL, THE PATIENT RECEIVED SHOCKS DUE TO SINUS TACHYCARDIA AND THESE EPISODES SHOWED POST-SHOCK. THE LEAD IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A HIGH SENSING INTEGRITY COUNT (SIC) SINCE (B)(6) WITH ONLY ONE NON-SUSTAINED TACHYCARDIA (NST) WITH NO SHORT INTERVALS STORED. LAST (B)(6) THE PATIENT RECEIVED SHOCKS DUE TO SINUS TACHYCARDIA AND THESE EPISODES SHOWED POST-SHOCK. THE LEAD IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE LEAD WAS STILL OVERSENSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSVENE IMPLANTABLE TACHY LEAD LWS MEDTRONIC, INC. 6936 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6933 IMPLANTABLE TACHY LEAD| 6933 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB