BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC ICD

    MDR report key: 1861640 · Received October 8, 2010

    Report

    Report Number
    6000094-2010-01855
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    June 12, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CHARGE TIME WAS 16.4 SECONDS. THE AUTO CAPACITOR FORMATION INTERVAL WAS REPROGRAMMED FROM 6 MONTHS TO 1 MONTH. IT WAS FURTHER REPORTED THAT AFTER ONE MANUAL CHARGE, THE CHARGE TIME WAS 7.3 SECONDS, CHARGING FROM 17 J TO 35 J, AND THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR. THE DEVICE HAS BEEN 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 ICD IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. 7272 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention 4193 IMPLANTABLE PACING LEAD| 5554 IMPLANTABLE PACING LEAD| 6944 IMPLANTABLE TACHY LEAD