BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW-IN

    MDR report key: 1990927 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02183
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    K902002
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN ATRIAL LEAD WARNING, WHICH ACTUALLY WAS THE LEFT VENTRICULAR LEAD IN THE ATRIAL PORT. IT WAS UNKNOWN AS TO HOW THE LEAD IS CONNECTED WHETHER IT IS CONNECTED DIRECTLY INTO THE DEVICE OR IF THIS ONE AND A SECOND LEAD ARE ADAPTED TOGETHER. MULTIPLE FOLLOW-UP ATTEMPTS YIELDED NO FURTHER INFORMATION. BOTH LEADS REMAIN 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
    1 SCREW-IN IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5071 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other 5034 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR| 4194 IMPLANTABLE PACING LEAD