BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIANCE 4-FRONT

    MDR report key: 9924631 · Received April 3, 2020

    Report

    Report Number
    2124215-2020-03517
    Event Type
    Malfunction
    Date Received
    April 3, 2020
    Date of Event
    February 3, 2020
    Report Date
    July 15, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION OF THE LEAD FOUND THAT THE HELIX MECHANISM WAS RETRACTED, AND REVEALED NO ABNORMALITIES. THE LEAD TIP APPEARED NORMAL. THE LEAD BODY APPEARED CURLED; HOWEVER, THIS IS CONSIDERED NORMAL AFTER IT HAD BEEN INVOLVED IN AN ATTEMPTED IMPLANT. TESTING WAS COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INNER/OUTER INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. LABORATORY ANALYSIS DID NOT IDENTIFY ANY LEAD CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING THE IMPLANT PROCEDURE, THE RIGHT VENTRICLE (RV) LEAD WAS SHOWING HIGHER IMPEDANCE MEASUREMENTS (>1300 OMHS), BUT WERE STILL WITHIN NORMAL RANGE. THIS OCCURRED DURING BOTH PRE AND POST EXPOSURE OF THE HELIX, AND TIGHTENING. THE PHYSICIAN REPOSITIONED THE LEAD THREE TIMES, AND AT THE THIRD ATTEMPT THE LEAD SHOWED AN IMPEDANCE OF 700 OHMS, AND NORMAL PACING THRESHOLD VALUES. THE LEAD APPEARED TO BE SAFELY POSITIONED AND STABLE. THE PHYSICIAN PROCEDEED TO IMPLANT THE RIGHT ATRIAL (RA) LEAD BUT DURING THE INSERTION, THE PHYSICIAN NOTICED THAT THE RV LEAD WAS DISLODGED. THE PHYSICIAN ALSO NOTICED THAT THE LEAD BODY FORMED A LOOP AFTER DISLODGEMENT. THEREFORE, THE DECISION WAS MADE TO REPLACE IT WITH ANOTHER LEAD. THE PATIENT PRESENTED NO ADVERSE EVENTS AND THE IMPLANT WAS CONCLUDED WITHOUT FURTHER COMPLICATIONS. ADDITIONAL INFORMATION: THIS REPORT HAS BEEN UPDATED TO INCLUDE FINAL ANALYSIS RESULTS.

    Additional Manufacturer Narrative · 1

    THE LEAD IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING THE IMPLANT PROCEDURE, THE RIGHT VENTRICLE (RV) LEAD WAS SHOWING HIGHER IMPEDANCE MEASUREMENTS (>1300 OMHS), BUT WERE STILL WITHIN NORMAL RANGE. THIS OCCURRED DURING BOTH PRE AND POST EXPOSURE OF THE HELIX, AND TIGHTENING. THE PHYSICIAN REPOSITIONED THE LEAD THREE TIMES, AND AT THE THIRD ATTEMPT THE LEAD SHOWED AN IMPEDANCE OF 700 OHMS, AND NORMAL PACING THRESHOLD VALUES. THE LEAD APPEARED TO BE SAFELY POSITIONED AND STABLE. THE PHYSICIAN PROCEEDED TO IMPLANT THE RIGHT ATRIAL (RA) LEAD BUT DURING THE INSERTION, THE PHYSICIAN NOTICED THAT THE RV LEAD WAS DISLODGED. THE PHYSICIAN ALSO NOTICED THAT THE LEAD BODY FORMED A LOOP AFTER DISLODGEMENT. THEREFORE, THE DECISION WAS MADE TO REPLACE IT WITH ANOTHER LEAD. THE PATIENT PRESENTED NO ADVERSE EVENTS AND THE IMPLANT WAS CONCLUDED WITHOUT FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388189 RELIANCE 4-FRONT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION 0672 104357

    Patients

    Seq Age Sex Outcome Treatment
    1