BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENE

    MDR report key: 3111794 · Received May 14, 2013

    Report

    Report Number
    2182208-2013-01131
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 20, 2013
    Manufacturer
    .
    Product Code
    LWS
    PMA / PMN Number
    P980050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER REVIEW PROMPTED A CHANGE IN THE DEVICE ANALYSIS RESULTS.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4): PRODUCT ID (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IMPLANTED: (B)(6) 2011; 4968 IMPLANTABLE PACING LEAD IMPLANTED: (B)(6) 2011; 6996 IMPLANTABLE TACHY LEAD IMPLANTED (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4) - THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND NO ANOMALIES WERE FOUND. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) DEFIBRILLATION COIL WAS BEYOND THE EXPECTED UPPER RANGE AND THE IMPEDANCE ON THE SVC (SUPERIOR VENA CAVA) DEFIBRILLATION COIL WAS BEYOND THE EXPECTED UPPER RANGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A RAPID INCREASE IN SUPERIOR VENA CAVA (SVC) AND RIGHT VENTRICULAR (RV) LEAD IMPEDANCE ON THE REMOTE MONITOR TRANSMISSION. THE HIGH IMPEDANCE WAS FOUND TO BE ISOLATED TO THE SVC COIL DURING TESTING AND THERE WAS AN APPARENT LEAD FRACTURE. THE LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A RAPID INCREASE IN SUPERIOR VENA CAVA (SVC) AND RIGHT VENTRICULAR (RV) LEAD IMPEDANCE ON THE REMOTE MONITOR TRANSMISSION. THE HIGH IMPEDANCE WAS FOUND TO BE ISOLATED TO THE SVC COIL DURING TESTING AND THERE WAS AN APPARENT LEAD FRACTURE. THE LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212360 TRANSVENE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS . 6937A-35

    Patients

    Seq Age Sex Outcome Treatment
    1 00008 YR Hospitalization| R