BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN STARFIX

    MDR report key: 3160454 · Received June 10, 2013

    Report

    Report Number
    2649622-2013-08033
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P060039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION NOTED THAT INFECTION OCCURRED. PRODUCT EVENT SUMMARY: (B)(4) THE DISTAL PORTION OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4). 8042B IMPLANTABLE PULSE GENERATOR (IPG) IMPLANTED: 2010 (B)(6); 5076-52 IMPLANTABLE PACING LEAD IMPLANTED: 2003 (B)(6); 5076-58 IMPLANTABLE PACING LEAD IMPLANTED: 2003 (B)(6); M7700 MECHANICAL HEART VALVE IMPLANTED 1996 (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POCKET EROSION HAD OCCURRED. THE LEFT VENTRICULAR LEAD WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259424 ATTAIN STARFIX DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419588

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| R