BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK DSP

    MDR report key: 1775490 · Received July 29, 2010

    Report

    Report Number
    2124215-2010-13321
    Event Type
    Malfunction
    Date Received
    July 29, 2010
    Date of Event
    June 21, 2010
    Report Date
    June 21, 2010
    Manufacturer
    HISTORICAL PUERTO RICO
    Product Code
    NVY
    Removal / Correction Number
    Z-1144/1145-9
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SURGICALLY ABANDONED. AS THE LEAD WILL NOT BE RETURNED, CLINICAL OBSERVATIONS CANNOT BE CONFIRMED. NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ANY ADDITIONAL INFORMATION RELATED TO THIS EVENT BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS CHRONIC RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD DID NOT CONVERT AT 21 JOULES (J) OR 31 J DURING DEFIBRILLATION THRESHOLD TESTING (DFT'S) AT THE DEVICE REPLACEMENT PROCEDURE. A LOUD 'POP' WAS HEARD WHEN THE 31 J SHOCK WAS DELIVERED. THE PATIENT WAS EXTERNALLY DEFIBRILLATED. UPON INTERROGATION, A LOW SHOCK IMPEDANCE FAULT SCREEN WAS DISPLAYED. SHOCK IMPEDANCE WAS LESS THAN 20 OHMS. SHOCK IMPEDANCE WAS 39 OHMS PRIOR TO DFT'S. TECHNICAL SERVICES (TS) DISCUSSED THAT THE SYSTEM MAY BE COMPROMISED AND THE LEAD AND DEVICE SHOULD NOW BE REPLACED. THE PHYSICIAN THOUGHT THAT INITIALLY THE PROXIMAL PIN WAS NOT ALL OF THE WAY INTO THE DEVICE HEADER. THE PIN WAS REMOVED FROM THE HEADER AND REINSERTED ALL OF THE WAY INTO THE CONNECTOR BLOCK. IMPEDANCE WAS TESTED AGAIN AND WAS 39-40 OHMS. TS STRONGLY EMPHASIZED REPLACING LEAD AND DEVICE. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK DSP IMPLANTABLE LEAD NVY HISTORICAL PUERTO RICO 0125

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR E102| 1860| 0185| T135| 4269| 4470| 0125| 1640