BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK DSP

    MDR report key: 2170013 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-10088
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    September 22, 2006
    Report Date
    June 2, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) TRANSVENOUS DEFIBRILLATION LEAD'S RATE/SENSE TERMINAL PIN WAS OBSERVED TO BE LOOSE BETWEEN THE DISTAL END OF THE RING ELECTRODE AND THE END OF THE PIN. THIS OBSERVATION WAS MADE DURING A ROUTINE DEVICE CHANGEOUT PROCEDURE. NO NOISE OR OUT-OF-RANGE LEAD MEASUREMENTS WERE ASSOCIATED WITH THE CLINICAL OBSERVATION. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONSULTANT DISCUSSED THE OPTION OF IMPLANTING A SEPARATE RATE/SENSE LEAD, AND CAPPING AND SURGICALLY ABANDONING THE RATE/SENSE PORTION OF THIS LEAD. NO ADVERSE PATIENT SYMPTOMS WERE ASSOCIATED WITH THE CLINICAL OBSERVATION, AND THE LEAD REMAINED IN SERVICE. APPROXIMATELY 56 MONTHS LATER, A BOSTON SCIENTIFIC FIELD REPRESENTATIVE REPORTED THAT ANOTHER MANUFACTURER'S REPRESENTATIVE ALLEGED THIS LEAD WAS MALFUNCTIONING AND EXHIBITING LEAD-ON-LEAD CONTACT WITH THE ATRIAL LEAD DUE TO THE PRESENCE OF NOISE ON THE RV CHANNEL OF STORED ELECTROGRAMS (EGMS). THERE WAS NO SUBSEQUENT DISCUSSION OF THE PREVIOUS CLINICAL OBSERVATION, AND THE CURRENT LEAD MEASUREMENTS ALSO WERE NORMAL. REVIEW OF THE EGMS SHOWED NOISE ON THE ATRIAL AND RV CHANNELS, WITH DURATION FROM APPROXIMATELY ONE TO SEVEN SECONDS, THAT APPEARS TO HAVE INHIBITED RV PACING. A HANDWRITTEN NOTATION ON THE CLINICAL REPORT FORM INDICATED THAT ELECTROMAGNETIC INTERFERENCE (EMI) WAS SUSPECTED AS A SOURCE OF THE NOISE IN ADDITION TO A POSSIBLE LEAD ISSUE. IT ALSO WAS REPORTED THAT THE PATIENT HAD PASSED AWAY. THERE WERE NO ALLEGATIONS THAT THE PATIENT DEATH WAS ASSOCIATED WITH THIS OBSERVATION, AND IT WAS NOT KNOWN IF THE INFORMATION FORWARDED TO BOSTON SCIENTIFIC WAS OBTAINED FROM A DEVICE CHECK PRIOR TO OR AFTER THE PATIENT'S DEATH. IT WAS NOT KNOWN IF THIS LEAD WAS EXPLANTED. THE REPRESENTATIVE SUBSEQUENTLY REPORTED BEING TOLD THE DEVICE MANUFACTURER'S ANALYSIS SHOWED A LOW OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENT HAD BEEN FOUND, WHICH WAS ALLEGED TO BE RELATED TO THIS LEAD'S COIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK DSP IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0125

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening 4269| 0125