BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC SENTRY

    MDR report key: 1803282 · Received August 17, 2010

    Report

    Report Number
    6000094-2010-01749
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    June 15, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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) BATTERY DEPLETION WAS NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED DUE TO ELECTIVE REPLACEMENT INDICATORS AND/OR OCCULT PROBLEM. NO PATIENT COMPLICATIONS WERE 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 62 YR Other 5076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| 4193 IMPLANTABLE PACING LEAD