BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 1874956 · Received October 19, 2010

    Report

    Report Number
    2649622-2010-11615
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    March 15, 2010
    Report Date
    February 25, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S17
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) NO ANOMALIES WERE FOUND HOWEVER, THERE WAS FOREIGN MATERIAL IN THE SETSCREW.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING THE PROCEDURE FOR A LEAD REPLACEMENT THAT WHEN THE LEAD WAS BEING CONNECTED TO THE DEVICE, THE SETSCREW OF THE ICD WOULD NOT PROPERLY SECURE THE LEAD IN PLACE. ANOTHER DEVICE WAS UTILIZED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS ISSUE. IT WAS REPORTED THAT THE DEFIBRILLATION LEAD HAD AN INSULATION BREAK. THE LEAD WAS CAPPED AND REPLACED. THERE WERE PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6944 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention