BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC SENTRY

    MDR report key: 2131937 · Received June 16, 2011

    Report

    Report Number
    6000094-2011-01267
    Event Type
    Injury
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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 AND ANALYSIS REVEALED NORMAL BATTERY DEPLETION. THERE WAS NO LONGEVITY TEST PERFORMED DUE TO BATTERY VOLTAGE AT ELECTIVE REPLACEMENT INDICATOR (ERI) ON (B)(6) 2008. BASED ON THIS DATA, THE TIME FROM ERI TO EXPLANT DATE IS GREATER THAN ONE YEAR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PROBLEMS SINCE THEIR FIRST DEVICE FAILED TO WARN THEM THAT THE BATTERY WAS DEAD. THE PATIENT STATED THAT THEY RUN OUT OF BREATH SOMETIMES. THE DEVICE WAS EXPLANTED AND REPLACED APPROXIMATELY ONE YEAR AGO. 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 S.A. 7297 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization| R 4076 IMPLANTABLE PACING LEAD| 4193 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD