BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 8621065 · Received May 17, 2019

    Report

    Report Number
    2649622-2019-08452
    Event Type
    Injury
    Date Received
    May 17, 2019
    Date of Event
    April 27, 2019
    Report Date
    May 17, 2019
    Manufacturer
    MPRI
    Product Code
    LWS
    UDI-DI
    00643169356566
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 EXPERIENCED AN INFECTION, AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND LEAD ERODED OUT OF THE POCKET. THE SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413283 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62 00643169356566

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R DVFB1D4 ICD