BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC SENTRY

    MDR report key: 1646173 · Received March 30, 2010

    Report

    Report Number
    6000094-2010-00668
    Event Type
    Injury
    Date Received
    March 30, 2010
    Date of Event
    February 11, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED OR CONFIRMED MALFUNCTION. EVALUATION SUMMARY: (B)(4) THE DEVICE CHARGED, BUT DID NOT DELIVER HIGH VOLTAGE THERAPIES DURING FUNCTIONAL TEST. FURTHER ANALYSIS FOUND GATE OXIDE DAMAGE IN A TRANSISTOR OF THE POR (POWER ON RESET) CIRCUIT BLOCK OF THE IGBT (INSULATED-GATE BIPOLAR TRANSISTOR) CONTROLLER IC (INTEGRATED CIRCUIT). THE GATE OXIDE DAMAGE CAUSED EXCESS DC LEAKAGE IN THE IGBT CONTROLLER IC WHEN THE HV (HIGH VOLTAGE) CIRCUITRY WAS ACTIVATED. THIS RESULTED IN NO HV THERAPY BEING DELIVERED.

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED OR CONFIRMED MALFUNCTION. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WENT TO HOSPITAL BECAUSE HE FELT BAD. THE PATIENT HAD FELT SYMPTOMS BECAUSE OF THE ARRHYTHMIA. DURING THE REVISION IN THE HOSPITAL, IT WAS SEEN THAT THE PATIENT HAD EPISODES OF VT WITH NO THERAPY ADMINISTERED. THE DEVICE DETECTED THE EPISODE BUT IT DID NOT ADMINISTER THE 35 J SHOCK (ONLY 0.3 J OR 0.0 J). THE DEVICE WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WENT TO HOSPITAL BECAUSE HE FELT BAD. THE PATIENT HAD FELT SYMPTOMS BECAUSE OF THE ARRHYTHMIA. DURING THE REVISION IN THE HOSPITAL, IT WAS SEEN THAT THE PATIENT HAD EPISODES OF VT (VENTRICULAR TACHYCARDIA) WITH NO THERAPY ADMINISTERED. THE DEVICE DETECTED THE EPISODE BUT IT DID NOT ADMINISTER THE 35 J SHOCK (ONLY 0.3 J OR 0.0 J). THE DEVICE WERE EXPLANTED AND 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 S.A. 7298 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 6949 IMPLANTABLE TACHY LEAD