BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIRTUOSO DR

    MDR report key: 1854767 · Received October 5, 2010

    Report

    Report Number
    6000144-2010-04428
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S062
    Removal / Correction Number
    Z-0128-2010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. CORRECTION: CHANGED ADVERSE EVENT TO 'YES' AND DATE OF DEATH FIELD TO 'NOT APPLICABLE'. EVALUATION SUMMARY: (B)(4) PERFORMANCE DATA COLLECTED FROM THE DEVICE SHOWED THE DEVICE REACHED ERI (ELECTIVE REPLACEMENT INDICATOR) ON (B)(4)2010 APPROXIMATELY 46 MONTHS AFTER IMPLANT. (B)(4) CERAMIC CAP ANALYSIS OF THE DEVICE FOUND A HIGH CURRENT DRAIN CONDITION. ELECTRICAL ANALYSIS REVEALED THE CAUSE OF THE HIGH CURRENT DRAIN WAS CURRENT LEAKAGE IN THE BATTERY FILTER CAPACITORS.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. CORRECTION: CHANGED ADVERSE EVENT TO 'YES' AND DATE OF DEATH FIELD TO 'NOT APPLICABLE'. EVALUATION SUMMARY: (B)(4) PERFORMANCE DATA COLLECTED FROM THE DEVICE SHOWED THE DEVICE REACHED ERI (ELECTIVE REPLACEMENT INDICATOR) ON (B)(6) 2010 APPROXIMATELY 46 MONTHS AFTER IMPLANT. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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 THE DEVICE HAD PREMATURE BATTERY DEPLETION. 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 THE DEVICE HAS PREMATURE BATTERY DEPLETION. 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 VIRTUOSO DR ASKU LWS MEDTRONIC MED REL, INC. D154AWG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| O| R 6949 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| 6949 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD