BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN STARFIX

    MDR report key: 7583329 · Received June 8, 2018

    Report

    Report Number
    2182208-2018-01084
    Event Type
    Injury
    Date Received
    June 8, 2018
    Date of Event
    January 1, 2017
    Report Date
    June 8, 2018
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    OJX
    PMA / PMN Number
    P060039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: THE WEARABLE CARDIOVERTER DEFIBRILLATOR AS A BRIDGE TO REIMPLANTATION IN PATIENTS WITH ICD OR CRT-D-RELATED INFECTIONS. JOURNAL OF CARDIOTHORACIC SURGERY. 2017; 12(1):99. DOI: 10.1186/S13019-017-0669-2. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING IMPLANTABLE PACING LEADS. THE ARTICLE REPORTS THE PATIENT DEVELOPED AN INFECTION REQUIRING REMOVAL OF THE SYSTEM. IT WAS NOTED THAT DURING THE LEAD EXTRACTION, A TEAR AT THE CORONARY SINUS OCCURRED. UNDER THE USE OF CARDIOPULMONARY BYPASS THE TEAR WAS SUCCESSFULLY PATCHED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425080 ATTAIN STARFIX DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MEDTRONIC, INC. 4195

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| L| R