BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURA DR

    MDR report key: 1798098 · Received August 12, 2010

    Report

    Report Number
    6000144-2010-04091
    Event Type
    Malfunction
    Date Received
    August 12, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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.

    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 AND NO ANOMALIES WERE FOUND. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. PRIMARY ANALYSIS FINDING: NO LEAD IMPEDANCE ANOMALIES WERE FOUND. ATRIAL IMPEDANCE RECORDED A VALUE OF 4047 AS A MAX READING THE FIRST WEEK OF THE RECORDING BUT SUBSEQUENT VALUES WERE CONSISTENT. INTERFERENCE/NOISE WAS NOTED. THE LIFETIME VENTRICULAR SENSING INTEGRITY COUNTER IS 231183. A HIGH VALUE OF THIS COUNT CAN INDICATE A POSSIBLE INTERMITTENCY IN THE SYSTEM.

    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. PRIMARY ANALYSIS FINDING: NO LEAD IMPEDANCE ANOMALIES WERE FOUND. ATRIAL IMPEDANCE RECORDED A VALUE OF 4047 AS A MAX READING THE FIRST WEEK OF THE RECORDING BUT SUBSEQUENT VALUES WERE CONSISTENT. INTERFERENCE/NOISE WAS NOTED. THE LIFETIME VENTRICULAR SENSING INTEGRITY COUNTER IS 231183. A HIGH VALUE OF THIS COUNT CAN INDICATE A POSSIBLE INTERMITTENCY IN THE SYSTEM.

    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. PRIMARY ANALYSIS FINDING: NO LEAD IMPEDANCE ANOMALIES WERE FOUND. ATRIAL IMPEDANCE RECORDED A VALUE OF 4047 AS A MAX READING THE FIRST WEEK OF THE RECORDING BUT SUBSEQUENT VALUES WERE CONSISTENT. INTERFERENCE/NOISE WAS NOTED. THE LIFETIME VENTRICULAR SENSING INTEGRITY COUNTER IS 231183. A HIGH VALUE OF THIS COUNT CAN INDICATE A POSSIBLE INTERMITTENCY IN THE SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THERE WAS EVIDENCE OF OVERSENSING. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS EVIDENCE OF OVERSENSING AND THAT A LEAD INTEGRITY ALERT TRIGGERED. THE DEVICE WAS EXPLANTED AND REPLACED AS THE PATIENT WAS UPGRADED TO A BI-VENTRICULAR IMPLANTABLE CARDIO DEFIBRILLATOR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THERE WAS EVIDENCE OF OVERSENSING AND THAT A LEAD INTEGRITY ALERT TRIGGERED. THE DEVICE IS STILL IN USE. 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 DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D224DRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other 1582 COMPETITIVE IMPLANTABLE TACHY LEAD| 1582 COMPETITIVE IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 1582 COMPETITIVE IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 1582 COMPETITIVE IMPLANTABLE TACHY LEAD