BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURA DR

    MDR report key: 1925401 · Received December 14, 2010

    Report

    Report Number
    6000144-2010-06308
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    September 17, 2010
    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
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. ANALYSIS INDICATES THAT A LEAD INTEGRITY ALERT TRIGGERED ON (B)(6) 2010. OVERSENSING WAS NOTED WITH FOUR VENTRICULAR NON-SUSTAINED TACHYARRHYTHMIA EPISODES WITH LESS THAN 200 MS AVERAGE VENTRICULAR CYCLE ON (B)(6) 2010.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PATIENT ALERT TRIGGERED DUE OVERSENSING, NOISE, AND ELEVATED THRESHOLD ON THE RIGHT VENTRICULAR LEAD, POSSIBLY DUE TO TWIDDLER'S SYNDROME. THE DEVICE REMAINS IN USE. THE DEVICE WAS REPROGRAMMED AND REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PATIENT ALERT TRIGGERED DUE OVERSENSING, NOISE, AND ELEVATED THRESHOLD ON THE RIGHT VENTRICULAR LEAD, POSSIBLY DUE TO TWIDDLER'S SYNDROME. THE DEVICE WAS REPROGRAMMED AND REMAINS IN USE. NO PATIENT COMPLICATIONS WERE 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 62 YR Required Intervention 5071 2X IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE LEAD ADAPTOR| 4076 IMPLANTABLE PACING LEAD| 5071 2X IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE LEAD ADAPTOR| (B)(4) IMPLANTABLE TACHY LEAD