BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2780473 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12947
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    April 1, 2012
    Report Date
    November 20, 2018
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    --

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE RETURNED PROXIMAL SEGMENT WAS PERFORMED. VISUAL INSPECTION NOTED THE LEAD HAD BEEN SEVERED 14 CM FROM THE IS-1 TERMINAL PIN. RESISTANCE AND PRESSURE TESTING CONFIRMED THE ELECTRICAL CONTINUITY AND INSULATION INTEGRITY OF THE RETURNED SEGMENT. THIS PRODUCT ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THIS LEAD WAS REMOVED FROM SERVICE DUE TO A PRODUCT PERFORMANCE ISSUE. THE PRODUCT IS BEING ANALYZED IN OUR POST MARKET QUALITY ASSURANCE LABORATORY. THIS PRODUCT ISSUE WILL BE UPDATED WHEN EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS DEVICE SYSTEM CONTINUED TO DETECT INCREASED RV PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. THE LOCAL AREA SALES REPRESENTATIVE DISCUSSED THAT LEAD REPLACEMENT WAS RECOMMENDED FOLLOWING LONG STANDING HIGH CAPTURE THRESHOLD AND PACING IMPEDANCE MEASUREMENTS, ALONG WITH NOISE ARTIFACT TRACINGS STORED DURING ELECTROGRAM REVIEW. THE PATIENT WITH THIS DEVICE SYSTEM RESPECTFULLY DECLINED TO PROCEED WITH FURTHER INTERVENTION. THE PHYSICIAN IS MONITORING THE PATIENT VIA HOME MONITORING AND MAINTAIN CLOSE SURVEILLANCE. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCE MEASUREMENTS TRENDED UPWARD, FINALLY REACHING GREATER THAN 2,000 OHMS. THRESHOLD MEASUREMENTS WERE ALSO INCREASED, HOWEVER, ELECTROGRAMS WERE WITHIN ACCEPTABLE LIMITS WITH ISOMETRIC TESTING. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R MISMATCH| 1762| 0125| 1860| E102| 0175