BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 1875344 · Received October 19, 2010

    Report

    Report Number
    2649622-2010-11672
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    May 4, 2010
    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
    AU
    Reporter Occupation
    PHYSICIAN

    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; FULL LEAD WAS RETURNED FOR ANALYSIS. FURTHER TESTING REVEALED DISTAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED) AND OUTER TUBING OVERLAY HAD MELTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD UNSTABLE THRESHOLD. THE LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE 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 Required Intervention D354TRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB