BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3212528 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09858
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT, IMPLANTED WITH THIS DEVICE, WAS INVOLVED IN A MOTORCYCLE ACCIDENT IN LATE-SEPTEMBER 2012. THE PATIENT'S CHEST AND TORSO CAME IN CONTACT WITH THE BACK OF THE AUTOMOBILE. APPROXIMATELY ONE-MONTH LATER, THE PATIENT WAS SEEN IN-CLINIC FOR A DEVICE CHECK. AT THAT TIME, NO ANOMALIES WERE IDENTIFIED AS THE FOLLOW-UP DEVICE EVALUATION WAS NORMAL. YESTERDAY, THE PATIENT WAS SEEN AGAIN IN-CLINIC. A DEVICE CHECK IDENTIFIED NOISE ON THE RIGHT VENTRICULAR (RV) PACE/SENSE CHANNEL. THIS CLINICAL OBSERVATION WAS ASSOCIATED WITH OVERSENSING AND PACING INHIBITION FOR 3 SECONDS (PATIENT IS PACEMAKER DEPENDENT). THE PATIENT DID NOT COMPLAIN OF ANY SYMPTOMS. THE CLINICAL OBSERVATION OF NOISE WAS REPRODUCED WITH PATIENT ISOMETRICS. DURING THIS TEST, THE PATIENT WAS ASYMPTOMATIC. THE PATIENT WAS SCHEDULED FOR A LEAD REVISION PROCEDURE WITH PLANS TO REPLACE THE DEVICE DUE AN ADVISORY. ATTEMPTS TO ACCESS THE LEFT SUBCLAVIAN VEIN WAS UNSUCCESSFUL DUE TO LEFT SUBCLAVIAN VEIN OCCLUSION. THE RV AND RIGHT ATRIAL (RA) LEADS WERE SURGICALLY CAPPED. ATTEMPTS TO IMPLANT A RV DEFIBRILLATION LEAD WAS UNSUCCESSFUL DUE TO POSITIONING DIFFICULTIES. A COMPETITOR RV DEFIBRILLATION LEAD WAS SUCCESSFULLY IMPLANTED AND ADEQUATE LEAD DIAGNOSTIC MEASUREMENTS WERE OBTAINED. DESPITE THE USE OF MULTIPLE COMPETITOR RA LEADS, ADEQUATE LEAD DIAGNOSTIC MEASUREMENTS COULD NOT BE OBTAINED. ADEQUATE RA LEAD DIAGNOSTIC MEASUREMENTS (3.2 MV AND 1.1 VOLTS AT .5 MS) WERE OBTAINED WITH IMPLANTATION OF ANOTHER COMPETITOR RA LEAD. VISUAL INSPECTION OF THE EXPLANTED DEVICE FOUND THAT THE HEADER WAS LOOSE AND BODILY FLUID IN THE HEADER NEAR THE FEED-THRU WIRES WAS VISIBLE. THE DEVICE WAS RECEIVED AT BOSTON SCIENTIFIC'S RETURN PRODUCTS DEPARTMENT. AN INSPECTION OF THE HEADER SEAL PLUGS DID IDENTIFY A HOLE IN THE RV TIP SEAL PLUG. HISTORICALLY, THIS TYPE OF LABORATORY FINDINGS COULD CONTRIBUTE TO THE CLINICAL OBSERVATION OF NOISE, OVERSENSING AND PACING INHIBITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313689 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R 4471| E110| 4469| 5076| E163| 0180| 0181| 4470| 7120| 0293