BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3153585 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06092
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    April 1, 2013
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE EXPOSED SVC (SUPERIOR VENA CAVA) DEFIBRILLATION AND EXPOSED RV (RIGHT VENTRICULAR) DEFIBRILLATION COILS BECAME EXTRINSICALLY DISTORTED DUE TO KINKING/BUCKLING. ALSO THE VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE.

    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): D314TRM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR 2012-(B)(6), 4195 IMPLANTABLE PACING LEAD 2012-(B)(6), 5076 IMPLANTABLE PACING LEAD 2010-(B)(6). (B)(4).

    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 THE RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEADS BOTH HAD TO BE REVISED DUE TO THE PATIENT¿S TWIDDLER SYNDROME. THE RV LEAD WAS UNABLE TO BE REPOSITIONED SO IT WAS EXPLANTED AND REPLACED. THE RA LEAD WAS DISLODGED AND WAS REPOSITIONED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259147 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R