BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN STARFIX

    MDR report key: 8260927 · Received January 18, 2019

    Report

    Report Number
    2649622-2019-01047
    Event Type
    Injury
    Date Received
    January 18, 2019
    Date of Event
    December 12, 2018
    Report Date
    February 20, 2019
    Manufacturer
    MPRI
    Product Code
    OJX
    UDI-DI
    00885074511955
    PMA / PMN Number
    P060039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PROXIMAL PORTION OF THE LEAD WAS RETURNED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. VISUAL ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 5112121 LEAD, IMPLANTED: (B)(6) 2017, EXPLANTED: (B)(6) 2017. DTMA1D1 ICD, IMPLANTED: (B)(6) 2017. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED WITH (B)(6), PROSTHETIC VALVE ENDOCARDITIS COMPLICATED BY ENDOPHTHALMITIS AND CEREBROVASCULAR ACCIDENT (CVA). THE PATIENT'S SYSTEM WAS REMOVED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53539 ATTAIN STARFIX DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419588 00885074511955

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R 693565 LEAD