BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3961743 · Received July 28, 2014

    Report

    Report Number
    2124215-2014-14530
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 16, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, AN EVALUATION OF THE LEAD WAS PERFORMED. A VISUAL INSPECTION OF THE LEAD PROXIMAL SEGMENT RETURNED INDICATES THAT THE LEAD WAS SEVERED FROM THE TERMINAL PIN. THE OBSERVATION AGAINST THE LEAD COULD NOT BE CONFIRMED BY ANALYSIS. THE LEAD SEGMENT PASSED ELECTRICAL TESTING. FURTHER, THE DAMAGE TO THE LEAD WAS CONSISTENT WITH DAMAGE CAUSED DURING EXPLANT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WITH THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW OUT-OF-RANGE (OOR) PACING LEAD IMPEDANCE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS AND RECOMMENDED BRINGING THE PATIENT IN FOR EVALUATION. ADDITIONAL INFORMATION INDICATES THAT THERE WAS NOISE ON THE LEAD AND A LEAD FRACTURE WAS SUSPECTED HOWEVER, WAS NOT CONCLUSIVELY DETERMINED. THE RV WAS SURGICALLY ABANDONED AND THE DEVICE WAS EXPLANTED AND NO LONGER IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439238 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R E110| 438-05| A155| 438-07| 4244| 0145| 294-09| 1831| 0184