BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S MRI SURESCAN

    MDR report key: 19087201 · Received April 11, 2024

    Report

    Report Number
    2649622-2024-10010
    Event Type
    Injury
    Date Received
    April 11, 2024
    Date of Event
    March 26, 2024
    Report Date
    April 11, 2024
    Manufacturer
    MPRI
    Product Code
    LWS
    UDI-DI
    00643169690042
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: 1572 LEAD IMPLANTED: (B)(6) 2005; 1488TC LEAD IMPLANTED: (B)(6) 2005. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS REMOVED DUE TO INFECTION. THE SYSTEM WAS 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
    695214 SPRINT QUATTRO SECURE S MRI SURESCAN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS MPRI 693565 00643169690042

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Hospitalization| R DDBB1D1 ICD