BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC SENTRY

    MDR report key: 1860910 · Received October 7, 2010

    Report

    Report Number
    6000144-2010-05018
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    July 14, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S18
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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) DEVICE DID NOT MEET EXPECTED LONGEVITY. THE DEVICE WAS FULLY FUNCTIONAL, WITH NO HIGH CURRENT DRAIN OR EVIDENCE OF BATTERY PROBLEMS. 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 THAT THE DEVICE PREVIOUSLY REGISTERED ERI (ELECTIVE REPLACEMENT INDICATOR) AND THE LEAD OUTPUTS WERE ADJUSTED DOWNWARD AND THE REPLACEMENT SCHEDULED. AT TIME OF REPLACEMENT, THE DEVICE DID NOT REGISTER ERI UPON INTERROGATION BUT THE PHYSICIAN PROCEEDED WITH ITS REPLACEMENT. IT WAS ALSO REPORTED, THERE WAS MUSCLE/NERVE STIMULATION WITH LEFT VENTRICULAR LEAD. THE DEVICE AND THE LEAD WERE REPLACED. 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 58 YR Required Intervention 4017 COMPETITIVE IMPLANTABLE PACING LEAD| 0155 COMPETITIVE IMPLANTABLE TACHY LEAD