BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURA DR

    MDR report key: 3153127 · Received June 8, 2013

    Report

    Report Number
    3004209178-2013-08879
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Removal / Correction Number
    Z-0115-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION.

    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. THERE WERE NO ANOMALIES FOUND. CONCOMITANT PRODUCT: 6947 2013-02-28; 4076 IMPLANTABLE PACING LEAD, (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEW DAYS AFTER A RIGHT VENTRICULAR (RV) LEAD REPLACEMENT, THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK. NOISE AND OVERSENSING WERE DETECTED ON THE REPLACEMENT RV LEAD. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)  WAS REVIEWED TO MAKE SURE THAT THERE WAS NOT A CONNECTION ISSUE SINCE DURING THE REPLACEMENT, THE PHYSICIAN INDICATED THAT THE TORQUE WRENCH "DID NOT FEEL RIGHT." THE PHYSICIAN DECIDED TO REPLACE THE ICD AND THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255346 SECURA DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D224DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization| L| R