BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURA DR

    MDR report key: 2203271 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-04319
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 27, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. THE RIGHT VENTRICULAR LEAD IS REPORTED ON E910899. EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED AND ANALYSIS REVEALED NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT IMPLANT THE PHYSICIAN FELT THAT THE DEVICE HAD BAD SET SCREWS BUT DURING THE PROCEDURE IT WAS DETERMINED THAT THE RIGHT VENTRICULAR LEAD WAS FRACTURED. THE DEVICE WAS NOT IMPLANTED AND ANOTHER DEVICE WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURA DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D224DRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other 6949 IMPLANTABLE TACHY LEAD| 5568 IMPLANTABLE PACING LEAD