BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURA DR

    MDR report key: 2964387 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02123
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    November 29, 2012
    Report Date
    November 29, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: 5076 IMPLANTABLE PACING LEAD, (B)(6) 2011. (B)(4). NO EVAL EXPLAINATION: DEVICE REMAINS IMPLANTED IN THE PATIENT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT REPORTED TO THE ER AFTER HAVING RECEIVED MULTIPLE INAPPROPRIATE THERAPIES DUE TO T-WAVE OVERSENSING. THE RIGHT VENTRICULAR (RV) SENSITIVITY WAS REPROGRAMMED WHICH ELIMINATED THE T-WAVE SENSING. THE VENTRICULAR TACHYCARDIA INTERVAL WAS ALSO CHANGED. THE DEVICE IS STILL 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
    66832 SECURA DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D224DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Hospitalization| L| R 6947 IMPLANTABLE TACHY LEAD