BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW-IN

    MDR report key: 1862564 · Received October 8, 2010

    Report

    Report Number
    2649622-2010-09935
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    April 27, 2010
    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
    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.

    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: (B)(4) PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED THAT THE SENSING VALUE WAS LOW, WHERE THE ATRIAL SENSING VALUE WAS AT ~0 MV OVER COURSE OF S2D TIMEFRAME. THERE WAS ALSO LOW ATRIAL IMPEDANCE/RESISTANCE, WITH ATRIAL IMPEDENCE STABLE AT ~150 OHMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BIPOLAR LEAD IMPEDANCE WAS LOW, 200 OHMS. THE LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BIPOLAR LEAD IMPEDANCE WAS LOW, 200 OHMS. IT WAS LATER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD ALSO HAD A LOW SENSING VALUE. THE LEAD WAS CAPPED 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 SCREW-IN IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4058M ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| O| R 5024M IMPLANTABLE PACING LEAD| 5024M IMPLANTABLE PACING LEAD| P1501DR IMPLANTABLE PULSE GENERATOR| P1501DR IMPLANTABLE PULSE GENERATOR