BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC ICD

    MDR report key: 2131527 · Received June 16, 2011

    Report

    Report Number
    6000094-2011-01260
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    April 14, 2003
    Manufacturer
    MEDTRONIC S.A.
    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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COMPLAINED OF CONTINUED PROBLEMS WITH SHORTNESS OF BREATH AND FATIGUE. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) IMPEDANCE WAS 235 OHMS AND THERE WAS A POSSIBLE LEAD FRACTURE, AND INTERROGATION REVEALED PROBLEMS WITH BOTH RV AND ATRIAL LEADS. THE RV AND RIGHT ATRIAL LEADS WERE REPOSITIONED. IT WAS ALSO REPORTED THAT POST-IMPLANT OF THE LEFT VENTRICULAR LEAD, THE PATIENT COMPLAINED OF LEFT CHEST PAIN "JUMPING". PROGRAMMING CHANGES WERE MADE THAT WERE SUCCESSFUL IN ELIMINATING THE DIAPHRAGMATIC PACING. LATER THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO OVERSENSING AND MYOPOTENTIALS, AND EXPERIENCED FURTHER DIAPHRAGMATIC PACING. THE LEFT VENTRICULAR LEAD WAS REPOSITIONED AND A LOOSE SETSCREW WAS NOTED. THE SETSCREW WAS TIGHTENED. THE PATIENT WAS LATER ADMITTED FOR A WOUND INFECTION. THE ENTIRE SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER 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 65 YR Hospitalization| R