BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 1989032 · Received February 14, 2011

    Report

    Report Number
    6000144-2011-00513
    Event Type
    Injury
    Date Received
    February 14, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S031
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY: (B)(4): WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. TIME OF ERI (ELECTIVE REPLACEMENT INDICATOR) IN SAVE TO DISK ON (B)(6) 2010 02:15:04, DEVICE RRT<=2.62 V. PATIENT ALERT FOR LOW BATTERY VOLTAGE ON (B)(6) 2010 02:15:04. WEEKLY BATTERY VOLTAGE TREND DATA SHOWS MIN BAT=2.64 TO 2.62 VOLTS BETWEEN (B)(6) 2010 AND (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. EVALUATION SUMMARY: (B)(4): WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. TIME OF ERI (ELECTIVE REPLACEMENT INDICATOR) IN SAVE TO DISK ON (B)(6) 2010 02:15:04, DEVICE RRT<=2.62 V. PATIENT ALERT FOR LOW BATTERY VOLTAGE ON (B)(6) 2010 02:15:04. WEEKLY BATTERY VOLTAGE TREND DATA SHOWS MIN BAT=2.64 TO 2.62 VOLTS BETWEEN (B)(6) 2010. ANALYSIS OF THE DEVICE FOUND NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD BATTERY VOLTAGE OF 2.9 V AND THEN ONE WEEK LATER WAS AT RRT (RECOMMENDED REPLACEMENT TIME). THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ASKU

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO CRT-D DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. C154DWK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R (B)(4) TISSUE VALVE| 4194 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD| (B)(4) TISSUE VALVE| 4592 IMPLANTABLE PACING LEAD| 4592 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| 6947 IMPLANTABLE TACHY LEAD