BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURA DR

    MDR report key: 2952584 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01751
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016/S216
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. DEVICE ANALYSIS WAS INCONCLUSIVE. PERFORMANCE DATA WAS ALSO COLLECTED FROM THE DEVICE AND WAS ANALYZED. IMPEDANCE/LOW IMPEDANCE: 1 - PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE BETWEEN (B)(6) 2012 15:00:18. DAILY PACE LEAD TREND DATA SHOWS A SPIKE DECREASE FOR VENTRICULAR PACE BI IMPEDANCE = 437 TO 76 OHMS MINIMUM BETWEEN (B)(6) 2012. 1 - PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE BETWEEN (B)(6) 2012 15:00:18. DAILY PACE LEAD TREND DATA SHOWS A SPIKE DECREASE FOR ATRIAL PACE BI IMPEDANCE= 494 TO 114 OHMS MINIMUM BETWEEN (B)(6) 2012. CONCOMITANT PRODUCTS: 5076 IMPLANTABLE PACING LEAD - (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MONTH AFTER IMPLANT, THE DEVICE EXHIBITED LOW/VARYING IMPEDANCE MEASUREMENTS FOR BOTH THE ATRIAL AND VENTRICULAR LEADS. AN X-RAY WAS PERFORMED, AND BOTH LEADS APPEARED TO BE INSERTED CORRECTLY INTO THE DEVICE. A DEVICE HEADER ISSUE WAS SUSPECTED, AND SUBSEQUENTLY THE DEVICE WAS EXPLANTED 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
    56874 SECURA DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D204DRM

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Hospitalization| R 6947M IMPLANTABLE TACHY LEAD