BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S MRI SURESCAN

    MDR report key: 8903025 · Received August 16, 2019

    Report

    Report Number
    2649622-2019-14511
    Event Type
    Injury
    Date Received
    August 16, 2019
    Date of Event
    August 1, 2019
    Report Date
    August 16, 2019
    Manufacturer
    MPRI
    Product Code
    LWS
    UDI-DI
    00643169309777
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    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 A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) APPEARED TO SHOW A GROWTH ON THE PROXIMAL PORTION OF THE RIGHT VENTRICULAR (RV) LEAD. AN INTRA-CARDIAC ECHO ULTRASOUND WAS COMPLETED AND THE GROWTH WAS NOT SEEN. THE PHYSICIAN CHOSE WAIT AND SEE IF ANY SYMPTOMS APPEAR AFTER A COURSE OF ANTIBIOTICS. AN INFECTION IS SUSPECTED. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RV LEAD CURRENTLY REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696614 SPRINT QUATTRO SECURE S MRI SURESCAN DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62 00643169309777

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention DVBB1D4, ICD