BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 4832641 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-07461
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    April 16, 2015
    Report Date
    April 16, 2015
    Manufacturer
    MEDTRONIC PR
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 4054 LEAD; IMPLANT DATE (B)(6) 2002. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ENDOCARDITIS OCCURRED. THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) 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
    376971 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PR 6947-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Hospitalization| R 4047-54 LEAD, DTBA1D1 ICD