BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC SENTRY

    MDR report key: 1802710 · Received August 17, 2010

    Report

    Report Number
    6000144-2010-04194
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    May 12, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S18
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 DID NOT MEET EXPECTED LONGEVITY. ANALYSIS OF THE DEVICE AND INTERNAL COMPONENTS WERE AS EXPECTED FOR A PACEMAKER AT ERI (ELECTIVE REPLACEMENT INDICATOR). 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. THE WRENCH WAS FOUND BENT AT THE TIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE DEVICE WAS BEING REMOVED DUE TO ELECTIVE REPLACEMENT INDICATORS (ERI), IT WAS DIFFICULT TO REMOVE THE WRENCH FROM THE DEVICE. NO 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 83 YR Required Intervention 6949 IMPLANTABLE TACHY LEAD| 4194 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD