BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 6009100 · Received October 6, 2016

    Report

    Report Number
    2182208-2016-02481
    Event Type
    Injury
    Date Received
    October 6, 2016
    Date of Event
    May 1, 2016
    Report Date
    August 1, 2016
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: IMPLANTABLE TACHY LEAD. THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. 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. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: MANAGEMENT OF A PREVIOUSLY UNREPORTED IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR LEAD COMPLICATION. EUROPACE. 2016; 18(5):1099-5129. DOI:10.1093/EUROPACE/EUV321.

    Additional Manufacturer Narrative · 1

    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 PATIENTIMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. THE ICD WAS BEING REMOVED FOR NORMAL BATTERY DEPLETION, ALONG WITH THE REMOVAL OF THE RIGHT VENTRICULAR (RV) LEAD. THE ARTICLE INDICATED THAT THE PATIENT UNDERWENT A PROCEDURE TO REPLACE THE RV LEAD. THE AUTHOR INDICATED THAT IT WAS A "TECHNICALLY CHALLENGING EXTRACTION/REPLACEMENT" PROCEDURE. IT WAS NOTED THAT DURING THE PROCEDURE, THE SUTURE SLEEVE "MIGRATED ALONG THE [NEW] LEAD INTO THE SUPERIOR VENA CAVA." THE PATIENT PRESENTED WITH POCKET EROSION SIX MONTHS LATER. THE REPLACEMENT LEAD AND THE SUTURE SLEEVE WERE REMOVED "AS A UNIT." FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658635 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 6935M55

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)