BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN STARFIX

    MDR report key: 3861583 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07224
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P060039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. THE OVERLAY TUBING OF THE LEAD WAS OBSERVED TO HAVE BLOOD INGRESSION. THE OVERLAY TUBING OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO KINKING/BUCKLING. THE LEAD WAS RECEIVED WITH THE LOBES NOT RETRACTED COMPLETELY AND THE OVERLAY TUBING BUCKLED. THE LOBES EXTEND/RETRACT TEST RESULT WAS: FAILED. THE ANALYST PERFORMED DESTRUCTIVE ANALYSIS AND FOUND DRIED BLOOD UNDER THE OVERLAY TUBING, PREVENTING THE LOBES FROM DEPLOYING.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 407652 LEAD, IMPLANTED: (B)(6) 2014; 6947M62 LEAD, IMPLANTED: (B)(6) 2014; 6570 (X'S 2) STENT, IMPLANTED: (B)(6) 1997. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DIAPHRAGMATIC STIMULATION. DURING A PROCEDURE TO REVISE THE LEAD, THE LOBES WOULD NOT RETRACT DESPITE SEVERAL ATTEMPTS, AND THE LEAD COULD NOT ADVANCE TO THE TARGET BRANCH. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342282 ATTAIN STARFIX DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419588

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Hospitalization| R DTBA1D4 ICD