BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC SENTRY

    MDR report key: 1072260 · Received July 10, 2008

    Report

    Report Number
    2647346-2008-00358
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    May 5, 2008
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    INVALID DATA

    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: NO ANOMALIES WERE FOUND. NO ANOMALIES FOUND; PROXIMAL SEGMENT RETURNED. IT WAS REPORTED THE DEVICE AND LEAD WERE EXPLANTED AND REPLACED DUE TO OVERSENSING. AFTER REPLACING THE LEAD, OVERSENSING WAS STILL OBSERVED WITH THE NEW LEAD, SO THE DEVICE WAS ALSO REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED ELECTRICAL TESTS PERFORMED, MECHANICAL TESTS PERFORMED, VISUAL EXAMINATION DEVICE PERFORMED ACCORDING TO SPECIFICATIONS DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED OVERSENSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE AND LEAD WERE EXPLANTED AND REPLACED DUE TO OVERSENSING. AFTER REPLACING THE LEAD, OVERSENSING WAS STILL OBSERVED WITH THE NEW LEAD, SO THE DEVICE WAS ALSO REPLACED. 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 DXY MEDTRONIC MED REL, INC. 7299 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R 7299 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4193 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD