BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW-IN

    MDR report key: 1920908 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12349
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    August 26, 2010
    Report Date
    February 27, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    K902002
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. EVALUATION SUMMARY: (B)(4) ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. ANALYSIS OF THE LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. CORRECTED DATA: (DATE OF DEATH TO NOT APPLICABLE, PATIENT OUTCOME CHECKED HOSPITALIZATION).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEVICE WAS INTERROGATED AND BATTERY VOLTAGE OF 2.62V WITH THE ERI FLAG NOT SET. THERE WAS CONCERN THAT DEVICE ONLY LASTED 3.5 YEARS. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS UNDERSENSING. THE RIGHT VENTRICULAR LEAD WAS EXPLANTED AND REPLACED. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR EPICARDIAL LEAD HAD INTERMITTENT CAPTURE. THE LEFT VENTRICULAR EPICARDIAL LEAD WAS CAPPED, AND ANOTHER EXISTING LEFT VENTRICULAR EPICARDIAL LEAD WAS CONNECTED. 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. 5071 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Hospitalization| R 5071-1 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 5071-1 IMPLANTABLE PACING LEAD