BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW-IN

    MDR report key: 2123475 · Received June 14, 2011

    Report

    Report Number
    2649622-2011-08130
    Event Type
    Injury
    Date Received
    June 14, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    K896313
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. EVALUATION SUMMARY FOR (B)(4): ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI) AND PREMATURE BATTERY DEPLETION WAS SUSPECTED DUE TO HIGH OUTPUTS. ALSO THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS BOTH HAD LOW IMPEDANCE. IT WAS ALSO NOTED THAT THE RV LEAD HAD A HIGH THRESHOLD AND THAT THE RA THRESHOLD COULD NOT BE TESTED DUE TO THE PATIENTS ATRIAL FIBRILLATION. THE DEVICE WAS EXPLANTED AND REPLACED AND BOTH LEADS WERE CAPPED AND REPLACED. 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. 4058M ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| R