BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW-IN

    MDR report key: 1791183 · Received August 10, 2010

    Report

    Report Number
    2649622-2010-07007
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    August 4, 2009
    Report Date
    February 24, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    K896313
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. CORRECTED OPERATOR CODE ON SDR303. EVALUATION SUMMARY: (B)(4) PRELIMINARY TESTING REVEALED THE DEVICE WAS AT ERI (ELECTIVE REPLACEMENT INDICATOR) AND PROGRAMMED TO VVI 65 BPM BIPOLAR MODE. TESTING ON THE AUTOMATED FUNCTIONAL TESTERS REVEALED ANOMALOUS OUTPUT CONDITIONS. THE NO OUTPUT CONDITION WAS THE RESULT OF LIFTED HYBRID BOND WIRES. ANALYSIS OF THE MEMORY DUMP INDICATED DATA RECORDING WAS TERMINATED DUE TO ERI ON (B)(6) 2009 WHICH IS BEFORE THE EXPLANT DATE OF (B)(6) 2009.

    Description of Event or Problem · 1

    THE DEVICE WAS REPLACED DUE TO ERI (ELECTIVE REPLACEMENT INDICATOR). THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. IT WAS FURTHER REPORTED THAT THERE WAS UNDEFINED HIGH IMPEDANCE ON THE ATRIAL LEAD. THE LEAD WAS 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 84 YR Male Required Intervention| O 4058 IMPLANTABLE PACING LEAD| 4058 IMPLANTABLE PACING LEAD