BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIANCE 4-FRONT

    MDR report key: 12139180 · Received July 8, 2021

    Report

    Report Number
    2124215-2021-18580
    Event Type
    Injury
    Date Received
    July 8, 2021
    Date of Event
    May 29, 2021
    Report Date
    September 21, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. THE LEAD WAS RETURNED AND THE MIDDLE AND TIP SEGMENTS WERE DEFORMED/STRETCHED OUT. THE PART OF THE INSULATIONS IN THE TIP SEGMENT APPEARED TO BE MISSING OR NOT RETURNED. VISUAL INSPECTION CONFIRMED SETSCREW MARKS ON THE TERMINAL PIN. RESISTANCE TESTING CONFIRMED ELECTRICAL OPENINGS AND AN X-RAY IMAGE DETERMINED THAT THE HV CABLE WAS FRACTURED APPROXIMATELY 12CM FROM THE TERMINAL END. THE IDENTIFIED FRACTURE IS THE LIKELY ROOT CAUSE OF THE REPORTED HIGH PACING IMPEDANCES AND HIGH SHOCK IMPEDANCES. THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, AND AS A RESULT, LABORATORY ANALYSIS COULD NOT BE CONDUCTED. THE RELATED INVESTIGATION DETERMINED THAT THIS LEAD WAS ASSOCIATED WITH A REPORTED PERFORATION WITH NO CONCLUSIVE EVIDENCE OF A MALFUNCTION; PLEASE REFER TO THE B5 DESCRIBE EVENT OR PROBLEM FOR MORE INFORMATION REGARDING THE SPECIFIC CIRCUMSTANCES OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING HIGH OUT OF RANGE PACING IMPEDANCE, MEASURING GREATER THAN 3000 OHMS AND SHOCK IMPEDANCE WAS MEASURING GREATER THAN 200 OHMS WITH NOISE SEEN ON BOTH CHANNELS OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. A LEAD FRACTURE OR LEAD PERFORATION WAS SUSPECTED BY THE PHYSICIAN. THE PATIENT WAS BELIEVED TO HAD FRACTURE THEIR LEAD DURING A RUGBY GAME, THE PATIENT HAD EXTREME CONTACT IN THE LEFT SHOULDER WITH ANOTHER PLAYER. THE PATIENT WAS BROUGHT INTO THE HOSPITAL FOR DEVICE DEACTIVATION. A LEAD REVISION WILL BE PERFORMED AT A LATER DATE BUT HAS YET TO BE SCHEDULED. ADDITIONALLY, THIS RV LEAD WAS EXPLANTED AND REPLACED. DURING THE EXPLANT PROCEDURE, THE LEAD WAS DAMAGED DURING THE EXTRACTION PROCESS AND WILL NOT RETURN FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONALLY, ON (B)(6) 2021, THE DEVICE WAS RECEIVED AT BOSTON SCIENTIFIC CORPORATION FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, AND AS A RESULT, LABORATORY ANALYSIS COULD NOT BE CONDUCTED. THE RELATED INVESTIGATION DETERMINED THAT THIS LEAD WAS ASSOCIATED WITH A REPORTED PERFORATION WITH NO CONCLUSIVE EVIDENCE OF A MALFUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING HIGH OUT OF RANGE PACING IMPEDANCE, MEASURING GREATER THAN 3000 OHMS AND SHOCK IMPEDANCE WAS MEASURING GREATER THAN 200 OHMS WITH NOISE SEEN ON BOTH CHANNELS OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. A LEAD FRACTURE OR LEAD PERFORATION WAS SUSPECTED BY THE PHYSICIAN. THE PATIENT WAS BELIEVED TO HAD FRACTURE THEIR LEAD DURING A RUGBY GAME, THE PATIENT HAD EXTREME CONTACT IN THE LEFT SHOULDER WITH ANOTHER PLAYER. THE PATIENT WAS BROUGHT INTO THE HOSPITAL FOR DEVICE DEACTIVATION. A LEAD REVISION WILL BE PERFORMED AT A LATER DATE BUT HAS YET TO BE SCHEDULED. ADDITIONALLY, THIS RV LEAD WAS EXPLANTED AND REPLACED. DURING THE EXPLANT PROCEDURE, THE LEAD WAS DAMAGED DURING THE EXTRACTION PROCESS AND WILL NOT RETURN FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1033443 RELIANCE 4-FRONT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION 0672 112047

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| R