BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN STARFIX

    MDR report key: 2811485 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16614
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    October 1, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P060039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REACHED BATTERY DEPLETION EARLY. THE DEVICE WAS EXPLANTED AND REPLACED. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) DISPLAYED HIGH THRESHOLD. THE LEAD 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) P DTB MEDTRONIC PUERTO RICO, INC. 4195

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD