BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3990873 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08435
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. PRODUCT EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED; ANALYSIS REVEALED A FLEX FRACTURE OF THE DISTAL CONDUCTOR. THE EXPOSED SVC (SUPERIOR VENA CAVA) DEFIBRILLATION COIL BECAME EXTRINSICALLY FRACTURED DUE TO A CUT. CONCOMITANT PRODUCTS: 4195-88C LEAD IMPLANTED 2006 (B)(6); 383059 LEAD IMPLANTED 2006 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INAPPROPRIATE SHOCKS DUE TO A RIGHT VENTRICULAR LEAD FRACTURE AND OVERSENSING. THE LEAD WAS EXPLANTED. DURING THE LEAD REPLACEMENT PROCEDURE, A LEAD WAS ATTEMPTED BUT NOT USED BECAUSE, IT WAS DIFFICULT TO IMPLANT AND THEN APPEARED KINKED. ANOTHER LEAD WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471030 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Hospitalization| L| R (B)(4) ICD