BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURA DR

    MDR report key: 2123893 · Received June 14, 2011

    Report

    Report Number
    6000144-2011-02385
    Event Type
    Injury
    Date Received
    June 14, 2011
    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
    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): THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. TWO - PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(4)-2011 15:00:03 AND (B)(4)-2011 03:00:04. WEEKLY HV LEAD IMPEDANCE TREND DATA SHOWS VARYING IMPEDANCE AND AN ABRUPT INCREASE FOR MIN AND MAX SVC DEFIB IMPEDANCE= 64 TO 228 OHMS PEAK, BETWEEN (B)(4)-2010 AND (B)(4)-2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM DUE TO HEARING A PATIENT ALERT. A DEVICE INTERROGATION SHOWED HIGH IMPEDANCE FROM THE RIGHT VENTRICULAR LEAD AND THE LEAD TRENDS SHOWED THAT THE IMPEDANCES VARIED. CHEST X-RAYS SHOWED AN APPARENT SUBCLAVIAN CRUSH AND A DEFINITIVE CHANGE IN SHAPE AND SIZE OF THE LEAD BODY. IT WAS FURTHER REPORTED THAT THE POCKET WAS OPENED AND IT WAS FOUND THAT THE LEAD PIN HAD BACKED OUT OF THE HEADER. THE LEAD WAS REINSERTED AND SCREWED IN. BOTH THE DEVICE AND LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN 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 51 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD