BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 1862874 · Received October 9, 2010

    Report

    Report Number
    6000144-2010-05041
    Event Type
    Injury
    Date Received
    October 9, 2010
    Date of Event
    July 21, 2010
    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
    MI, 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.

    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 MET 94% OF EXPECTED LONGEVITY. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEVICE INTERROGATION RESULTED IN INVALID DATA. IT WAS ALSO NOTED THAT THE PATIENT WAS NEAR THE END OF RECEIVING RADIATION THERAPIES. 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 DEVICE INTERROGATION RESULTED IN INVALID DATA. IT WAS ALSO NOTED THAT THE PATIENT WAS NEAR THE END OF RECEIVING RADIATION THERAPIES. IT WAS LATER REPORTED THAT THE BATTERY VOLTAGE HAD DEPLETED IN A SHORT TIME PERIOD. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEVICE INTERROGATION RESULTED IN INVALID DATA. IT WAS ALSO NOTED THAT THE PATIENT WAS NEAR THE END OF RECEIVING RADIATION THERAPIES. IT WAS LATER REPORTED THAT THE BATTERY VOLTAGE HAD DEPLETED IN A SHORT TIME PERIOD. IT WAS THEN REPORTED LATER THAT THE DEVICE HAD REACHED ERI (ELECTIVE REPLACEMENT INDICATOR). THE DEVICE WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    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 70 YR Hospitalization| O| R 2872 IMPLANTABLE LEAD ADAPTOR| 2187 IMPLANTABLE PACING LEAD| 6932 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 2872 IMPLANTABLE LEAD ADAPTOR| 6932 IMPLANTABLE TACHY LEAD| 6932 IMPLANTABLE TACHY LEAD| 2187 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 2187 IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD| 2872 IMPLANTABLE LEAD ADAPTOR