BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 8528379 · Received April 18, 2019

    Report

    Report Number
    2649622-2019-06587
    Event Type
    Injury
    Date Received
    April 18, 2019
    Date of Event
    February 12, 2019
    Report Date
    April 18, 2019
    Manufacturer
    MPRI
    Product Code
    LWS
    UDI-DI
    00613994446350
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: DTBA1Q1 ICD, IMPLANTED: (B)(6) 2018; 459878 LEAD, IMPLANTED: (B)(6) 2018. PRODUCT EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED IN SEGMENTS, ANALYZED. ANALYSIS INDICATED THAT THE RIGHT VENTRICULAR DEFIBRILLATION COIL DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. THE PROXIMAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. THE INITIAL REPORTED EVENT OF INFECTION WAS RECEIVED ON (B)(6) 2019. OF NOTE THE SERIOUS INJURY IS NORMALLY SUBMITTED VIA AN ALTERNATIVE SUMMARY REPORT THAT WOULD HAVE BEEN DUE ON 2019-03-14. INFORMATION WAS SUBSEQUENTLY RECEIVED ON 2109-04-17 AND REVEALED AN OUT OF SPECIFICATION ANALYSIS FINDING. AS THIS NEW INFORMATION DOES NOT QUALIFY FOR SUMMARY REPORTING, THIS REPORT IS THEREFORE BEING SUBMITTED AS A 30-DAY REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. ANTIBIOTIC TREATMENT WAS NECESSARY. THE DEVICE AND LEADS WERE EXPLANTED AND LATER REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321567 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565 00613994446350

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R ICF09B52 LEAD