BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURA DR

    MDR report key: 1926333 · Received December 14, 2010

    Report

    Report Number
    6000144-2010-06411
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    October 6, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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) PRELIMINARY FUNCTIONAL TESTING REVEALED THE DEVICE DID NOT RECORD AN IMPEDANCE VALUE OR PACING OUTPUT. FURTHER TESTING REVEALED THE CAUSE TO BE DUE TO GATE OXIDE LEAKAGE IN AN INTEGRATED CIRCUIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT THE DEVICE WAS UNABLE TO TRANSMIT READINGS OF IMPEDANCE TO PROGRAMMER. NO SENSING OR PACING WERE PRESENT. THE DEVICE WAS EXPLANTED 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 SECURA DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D224DRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other