BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S MRI SURESCAN

    MDR report key: 4162972 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12514
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    November 8, 2013
    Report Date
    February 24, 2022
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITHIN TWO DAYS OF THE IMPLANT PROCEDURE, THE RIGHT VENTRICULAR LEAD DISLODGED. AN ECHOCARDIOGRAM REVEALED THE TIP OF THE LEAD WAS THROUGH, BUT NOT NECESSARILY PAST, THE APICAL FREE WALL; IT WAS NOTED THERE WAS NO CLEAR EVIDENCE OF A PERFORATION AND THERE WAS NO EFFUSION. THE PATIENT WAS EXPERIENCING INTERMITTENT "PULSATIONS" IN THE LOWER LEFT CHEST/COSTAL MARGIN WHICH WERE CORRELATED BY THE PATIENT TO OCCUR WHEN THE LEAD PACED AND THE PATIENT ALSO NOTED VISIBLE MOTION/PULSATION UNDER THE SKIN. THE LEAD WAS REPOSITIONED AND REMAINS IN USE. THE PATIENT WAS A PARTICIPANT IN THE PRODUCT SURVEILLANCE REGISTRY STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639262 SPRINT QUATTRO SECURE S MRI SURESCAN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS MPRI 6935M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Male Hospitalization| R 4076-52 LEAD, DDBB1D4 ICD| 4076-52 LEAD, DDBB1D4 ICD