BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC SENTRY

    MDR report key: 2131599 · Received June 16, 2011

    Report

    Report Number
    6000144-2011-03527
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    July 27, 2007
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S18
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED AND THE BATTERY DEPLETION WAS NORMAL.

    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, ANALYZED AND THE BATTERY DEPLETION WAS NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LAWSUIT ALLEGED THAT THE PATIENT SUSTAINED INJURIES FROM THE DEFIBRILLATOR. THE PATIENT RECEIVED MULTIPLE SHOCKS WHICH WERE SUSPECTED TO BE DUE TO A LEAD FRACTURE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LAWSUIT ALLEGED THAT THE PATIENT SUSTAINED INJURIES. IT WAS ALSO REPORTED THAT THE PATIENT'S DEVICE WAS REMOVED AS A RESULT OF PREMATURE BATTERY DEPLETION, WHICH WAS DUE TO MULTIPLE SHOCKS DUE TO LEAD FRACTURE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC SENTRY IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. 7299 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R 4076 IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| 6949 IMPLANTABLE TACHY LEAD| 4194 IMPLANTABLE PACING LEAD