BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC SENTRY

    MDR report key: 1922146 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-05869
    Event Type
    Injury
    Date Received
    December 13, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B)(4): WRITE TO LOCKED RAM POR ON (B)(6) 2010 CLEARED ALL IMPLANT DATA. NO LONGEVITY CALCULATION CAN BE PERFORMED. (B)(4): PARTS OF THE LEAD IN SEGMENTS WERE RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. BLOOD/BODY FLUID WAS PRESENT ON THE OUTER TUBING OVERLAY AND IN/ON THE HELIX MECHANISM. THE DISTAL AND DEFIB CONDUCTORS WERE DISTORTED. THE OUTER TUBING WAS KINKED/BUCKLED. THE OUTER INSULATION WAS MELTED AND HAD A COSMETIC DEPRESSION. THE OUTER TUBING OVERLAY WAS MELTED AND HAD COSMETIC ENVIRONMENTAL STRESS CRACKS. THE HELIX WAS DISTORTED/BENT. THERE WAS APPARENT EXPLANT DAMAGE. THE LEAD IS PART OF THE ADVISORY FOR THIS MODEL.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY (B)(4) RAM CHIP - MEMORY ERROR; WRITE TO LOCKED RAM POR ON (B)(6) 2010. ALL IMPLANT DATA CLEARED. NO LONGEVITY CALCULATION CAN BE PERFORMED. THE LEAD IS PART OF THE ADVISORY FOR THIS MODEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD HIGH THRESHOLD AND WAS UNDERSENSING. THE DEVICE AND LEAD WERE RETURNED TO THE MANUFACTURER AND THE DEVICE TESTED OUT OF SPECIFICATION. THE DEVICE AND LEAD WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD HIGH THRESHOLD AND WAS UNDERSENSING. THE DEVICE AND LEAD WERE RETURNED TO THE MANUFACTURER, AND THE DEVICE TESTED OUT OF SPECIFICATION AFTER BEING EXPLANTED DUE TO NORMAL BATTERY DEPLETION. THE DEVICE AND LEAD WERE EXPLANTED AND 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 NIK MEDTRONIC MED REL, INC. 7297 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R 4193 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 4193 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD