BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S MRI SURESCAN

    MDR report key: 3862558 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06814
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    July 29, 2013
    Report Date
    October 6, 2020
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    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: 5076-45 LEAD IMPLANTED: (B)(6) 2013; D314TRM ICD, IMPLANTED: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A SUDDEN RISE IN CAPTURE THRESHOLDS AND THE THRESHOLD WAS HIGH. THE PARAMETERS ON THE LEAD WERE REPROGRAMMED AND THE LEAD REMAINS IN USE. IT WAS NOTED THAT THE PATIENT IS TAKING PART IN THE PRODUCT SURVEILLANCE REGISTRY STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340972 SPRINT QUATTRO SECURE S MRI SURESCAN DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M55

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention 4194-78 LEAD| 4194-78 LEAD