BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3212606 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08945
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 27, 2013
    Report Date
    October 8, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, TWO LEAD SEGMENTS WERE RETURNED. THE LEAD HAD BEEN SEVERED 116 MM FROM THE TERMINAL PIN. VISUAL OBSERVATION REVEALED CUTS IN THE LEAD INSULATION AT 173MM FROM THE TERMINAL PIN AND IN THE SUTURE SLEEVE. A SUTURE WAS TIED AROUND THE LEAD BODY INSULATION OF THE TIP SEGMENT FOR EXTRACTING PURPOSES. BLOOD AND BODY FLUID WERE NOTED THROUGHOUT THE HELIX MECHANISM. ANALYSIS DETERMINED THE LEAD WAS ELECTRICALLY CONTIGUOUS, HOWEVER DUE TO THE CONDITION OF THE LEAD, DETAILED ANALYSIS COULD NOT BE PERFORMED AND ANALYSIS COULD NOT CONFIRM THE REPORTED CLINICAL ALLEGATIONS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    - -

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS RIGHT VENTRICULAR LEAD AND DEVICE DISPLAYED INCREASED THRESHOLD MEASUREMENTS AND NOISE. IN ADDITION, VARIABLE SHOCK IMPEDANCE MEASUREMENTS WERE DISPLAYED INCLUDING SOME HIGH OUT OF RANGE MEASUREMENTS. IT WAS THOUGHT THERE WAS LEAD SUBCLAVIAN CRUSH OR AN INSULATION BREACH. A REVISION PROCEDURE WAS PERFORMED. UPON REMOVAL, VISUAL INSPECTION DID NOT REVEAL ANY INSULATION ISSUE; HOWEVER IT WAS THOUGHT THERE MIGHT BE AN INSULATION ISSUE AT THE PROXIMAL END NEAR THE CLAVICLE. THE LEAD WAS REPLACED SUCCESSFULLY AND RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DID NOT RESULT IN INAPPROPRIATE SHOCKS OR A LOSS OF CRITICAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311946 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0295

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R 4480| 0295| E162