BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK PLUS

    MDR report key: 2171559 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-10068
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 6, 2011
    Report Date
    September 8, 2011
    Manufacturer
    HISTORICAL PUERTO RICO
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT THE LEAD WAS LATER NOTED TO BE FRACTURED. INCREASED LEAD IMPEDANCES AND NOISE DURING INTERROGATION WERE NOTED. IT WAS NOTED THAT THE PATIENT'S ABDOMINALLY IMPLANTED SYSTEM WOULD BE ABANDONED AND REPLACED. ADDITIONAL INFORMATION WAS PROVIDED THAT THE LEAD WAS EXPLANTED AND REPLACED WITH A NON BOSTON SCIENTIFIC LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS DEFIBRILLATION LEAD EXHIBITED SHOCK IMPEDANCES OF GREATER THAN 200 OHMS WITH A NON - BOSTON SCIENTIFIC DEVICE. IT WAS NOTED THAT THIS MEASUREMENT ALERT WAS WITH THE SUPERIOR VENA CAVA (SVC) COIL, THUS IT WAS QUESTIONED IF THIS LEAD HAD AN SVC COIL. TECHNICAL SERVICES (TS) DISCUSSED THAT THE LEAD DID HAVE AN SVC COIL AND THAT IT WAS POSSIBLE THERE WAS AN ISSUE WITH THIS PORTION OF THE LEAD. IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) COIL TO CAN IMPEDANCE WAS 59 OHMS. THIS WAS GOING TO BE INVESTIGATED FURTHER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK PLUS IMPLANTABLE LEAD LWS HISTORICAL PUERTO RICO 0075

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| L| R (B)(4)| 0075