BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURA DR

    MDR report key: 3202571 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-11197
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 5, 2013
    Report Date
    September 9, 2013
    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
    AK, 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. (B)(4): 6935 IMPLANTABLE TACHY LEAD IMPLANTED ON 2009-(B)(6); 4469 COMPETITOR IMPLANTABLE PULSE GENERATOR (IPG) IMPLANTED: 2009-(B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY : (B)(4) THE DEVICE WAS RETURNED, ANALYZED AND ANALYSIS REVEALED A BROKEN ANTENNA WIRE NEAR THE ANTENNA COIL.

    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 THE CLINIC WAS UNABLE TO GET TELEMETRY WITH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). WIRELESS AND NONWIRELESS TELEMETRY WERE ATTEMPTED WITHOUT SUCCESS AND MULTIPLE PROGRAMMERS WERE ATTEMPTED. IT WAS FURTHER REPORTED THAT A SOLID STEADY ALERT TONE WAS HEARD WITH MAGNET APPLICATION. THE DEVICE WAS UNABLE TO BE INTERROGATED AND PROGRAMMED. IT WAS NOTED THAT THE PATIENT HAS A HISTORY OF WELDING WHILE HAVING THE ICD IMPLANT AND A SUCCESSFUL INTERROGATION OCCURRED TWO MONTHS PRIOR. THE DEVICE WAS REMOVED 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
    302919 SECURA DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D224DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00016 YR Hospitalization| R