BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURA DR

    MDR report key: 1923262 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-06072
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    August 24, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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: (B)(4) NO ANOMALIES FOUND. EVALUATION SUMMARY (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAD INTEGRITY ALERT (LIA) TONES TRIGGERED DUE TO OVERSENSING. AT THE EXPLANT, NO HEADER OR SET SCREW ISSUES WERE OBSERVED AND THE NOISE COULD NOT BE REPLICATED. THE PHYSICIAN CHOOSE TO REPLACE THE DEVICE. IN ADDITION, A NEW LEAD WAS PLACED FOR PACING AND SENSING AND THE HIGH VOLTAGE PORTION OF THE LEAD REMAINS IN USE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURA DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D224DRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| O| R 5554 IMPLANTABLE PACING LEAD