BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURA VR

    MDR report key: 2205709 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-04981
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    June 16, 2011
    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
    NY, 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. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED AND ANALYZED. THE GROMMET WAS DAMAGED. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. VENTRICULAR SHORT INTERVAL COUNT V-SIC=210.5 COUNTS AVG/DAY, IN 6.73 DAYS, BETWEEN (B)(6) 2011 21:56:03 AND (B)(6) 2011 09:00:04.

    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. VENTRICULAR SHORT INTERVAL COUNT V-SIC=210.5 COUNTS AVG/DAY, IN 6.73 DAYS, BETWEEN (B)(6) 2011 21:56:03 AND (B)(6) 2011 09:00:04.

    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 DEVICE WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. VENTRICULAR SHORT INTERVAL COUNT V-SIC=210.5 COUNTS AVG/DAY, IN 6.73 DAYS, BETWEEN (B)(6) 2011 21:56:03 AND (B)(6) 2011 09:00:04.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS ELEVATED OVERSENSING WITHIN ONE WEEK OF IMPLANT. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS ELEVATED OVERSENSING WITHIN ONE WEEK OF IMPLANT. THE DEVICE WAS EXPLANTED AND REPLACED. IT WAS FURTHER REPORTED THAT THERE WERE SENSING DIFFICULTIES, RAPID NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) EPISODES, NOISE, MYOPOTENTIAL OVERSENSING AND SHORT V-V INTERVALS. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED PAIN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURA VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D224VRC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R 0184 COMPETITOR IMPLANTABLE TACHY LEAD| 0184 COMPETITOR IMPLANTABLE TACHY LEAD| 0184 COMPETITOR IMPLANTABLE TACHY LEAD