BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 9167831 · Received October 8, 2019

    Report

    Report Number
    2182208-2019-01802
    Event Type
    Injury
    Date Received
    October 8, 2019
    Date of Event
    January 1, 2018
    Report Date
    December 12, 2019
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0067-2008-6949
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE BASELINE GENDER/AGE OF THE PATIENTS REPRESENTED IN THE ARTICLE IS MALE/55 YEARS OLD. OF NOTE, MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE MANUFACTURER/DEVICE SERIAL NUMBERS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. POSSIBLE MODELS COULD INCLUDE THE SPRINT FIDELIS (6931 AND 6949). THE RECALL AND CORRECTION NUMBER LISTED ARE IN REFERENCE TO A PRODUCT FAMILY OF LEADS THAT ARE ASSOCIATED WITH THE FIELD ACTION. WITHOUT THE SPECIFIC MODEL NUMBER(S), IT IS NOT POSSIBLE TO ASSURE THE SPECIFIC PRODUCT CORRECTION NUMBER REFERENCED IN THE ARTICLE IS LISTED IN THIS REPORT. WITHOUT THE SPECIFIC MODEL NUMBER(S ), IT IS NOT POSSIBLE TO ASSURE THE SPECIFIC PRODUCT CORRECTION NUMBER REFERENCED IN THE ARTICLE IS LISTED IN THIS REPORT. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: ¿ COMPARISON OF LEAD FAILURE MANIFESTATION OF BIOTRONIK LINOX WITH ST. JUDE MEDICAL RIATA AND MEDTRONIC SPRINT FIDELIS LEAD.¿ JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY. 2019; 54(2):161-170. 10.1007/S10840-018-0486-0. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. [(B)(4)].

    Additional Manufacturer Narrative · 1

    CORRECTION: FURTHER REVIEW PROMPTED A CHANGE IN THE DEVICE ANALYSIS RESULTS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS LEAD FAMILY. THE ARTICLE REPORTED THAT THERE WERE PATIENTS WHO EXPERIENCED INAPPROPRIATE SHOCKS. THERE WERE LEAD INSULATION ISSUES, OVERSENSING, UNDERSENSING, DIMINISHED SENSING, RISING THRESHOLDS, IMPEDANCE CHANGES, APPARENT FRACTURES, NON-PHYSIOLOGICAL HIGH RATE SIGNALS (OVERSENSING), AND LEAD RECALLS. THE LEADS WERE REPLACED/EXTRACTED, AND SOME LEADS WERE RETURNED FOR ANALYSIS. OF NOTE, MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL NUMBERS. THE STATUS/LOCATION OF THE LEAD IS UNKNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS LEAD FAMILY. THE ARTICLE REPORTED THAT THERE WERE PATIENTS WHO EXPERIENCED INAPPROPRIATE SHOCKS. THERE WERE LEAD FRACTURES, INSULATION ISSUES, OVERSENSING, DIMINISHED SENSING, RISING THRESHOLDS, IMPEDANCE CHANGES, AND NON-PHYSIOLOGICAL HIGH RATE SIGNALS. THERE WERE ALSO PATIENTS WHO HAD INFECTIONS REPORTED. THE LEADS WERE REPLACED/EXTRACTED, AND SOME LEADS WERE RETURNED FOR ANALYSIS. OF NOTE, MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL NUMBERS. THE STATUS/LOCATION OF THE LEAD IS UNKNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960084 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. MDT-FIDELIS-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)