BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3993111 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09480
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    January 27, 2014
    Report Date
    May 23, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 THE RIGHT VENTRICULAR (RV) LEAD HAD BECOME DISLODGED AND PULLED OUT OF THE RIGHT VENTRICLE. THE RV LEAD WAS EXPLANTED AND REPLACED SUCCESSFULLY. IT WAS FURTHER DETERMINED THAT THE PATIENT EXHIBITED TWIDDLER SYNDROME, AND IT WAS FURTHER CONFIRMED VIA X-RAY THAT THE DEVICE SEEMED TO BE LOWER IN THE CHEST THAN AT IMPLANT. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT DURING THE DEVICE CHECK, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN ABRUPT DECREASE IN R-WAVE AMPLITUDE AND CHANGES IN BOTH THE PACING AND DEFIBRILLATION IMPEDANCE. IN ADDITION, NEW ONSET OF FAR-FIELD SENSING OF ATRIAL ACTIVITY WERE NOTED IN THE VENTRICULAR CHANNEL. THE FINDINGS WERE CONSISTENT WITH AN RV LEAD DISLODGEMENT WHICH WAS SUBSEQUENTLY CONFIRMED BY A CHEST X-RAY. THE PATIENT IS A PARTICIPANT 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
    467428 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Hospitalization| R (B)(4) ICD