BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN STARFIX

    MDR report key: 2813017 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16231
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    January 27, 2012
    Report Date
    January 16, 2013
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P060039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. THERE WAS A PATIENT ALERT OF OUT OF TOLERANCE SUB THRESHOLD LEAD IMPEDANCE ON (B)(6) 2012. THE PROGRAMMER DATA SHOWED AN ALERT EVENT FOR "LEFT VENTRICULAR (LV) LEAD RING TO RIGHT VENTRICULAR (RV) LEAD COIL IMPEDANCE GREATER THAN 3000 OHMS" ON (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ALERT FOR LEFT VENTRICULAR (LV) LEAD HIGH IMPEDANCE. THE LV LEAD WAS REPROGRAMMED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN STARFIX DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 4195

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD