BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO II CRT-D

    MDR report key: 2202938 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-04046
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S125
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. (B)(4). EVALUATION SUMMARY: (B)(4) THE DEVICE MET 97% 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 THE DEFIBRILLATOR LONGEVITY IS LESS THAN EXPECTED FOR PROGRAMMED VALUES. THE DEVICE WILL BE SCHEDULED TO BE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEFIBRILLATOR LONGEVITY IS LESS THAN EXPECTED FOR PROGRAMMED VALUES. THE DEVICE WILL BE SCHEDULED TO BE REMOVED AND REPLACED. IT WAS ADDITIONALLY REPORTED THAT THE DEVICE HAD PREMATURE BATTERY DEPLETION. IT WAS FURTHER REPORTED THAT THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR AND WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEFIBRILLATOR LONGEVITY IS LESS THAN EXPECTED FOR PROGRAMMED VALUES. THE DEVICE WILL BE SCHEDULED TO BE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS ADDITIONALLY REPORTED THAT THE DEVICE HAD PREMATURE BATTERY DEPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO II CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D274TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R 1156T COMPETITOR IMPLANTABLE PACING LEAD| 1156T COMPETITOR IMPLANTABLE PACING LEAD| 7122 COMPETITOR IMPLANTABLE TACHY LEAD| 7122 COMPETITOR IMPLANTABLE TACHY LEAD| 1156T COMPETITOR IMPLANTABLE PACING LEAD| 7122 COMPETITOR IMPLANTABLE TACHY LEAD