BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW-IN

    MDR report key: 2812284 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-17424
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    K940703
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A ROUTINE DEVICE CHANGEOUT THAT THE RIGHT ATRIAL (RA) LEAD HAD ONE INSULATION BREACH AND THE RIGHT VENTRICULAR (RV) LEAD HAD THREE INSULATION BREACHES THAT WERE COVERED WITH A SLEEVE AND MEDICAL ADHESIVE. TWO EPISODES OF NOISE WERE SEEN ON THE ATRIAL AND VENTRICULAR ELECTROGRAMS (EGMS). THE HIGH VOLTAGE PORTION AND THE SUPERIOR VENA CAVA (SVC) PORTION OF THE RV LEAD WERE CAPPED. THE PACE/SENSE PORTION OF THE RV LEAD AND THE RA LEAD 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. 4558M

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB