BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN SELECT II

    MDR report key: 5382561 · Received January 21, 2016

    Report

    Report Number
    5382561
    Event Type
    Malfunction
    Date Received
    January 21, 2016
    Date of Event
    October 2, 2015
    Report Date
    November 19, 2015
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    OJX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CARDIOLOGIST'S CONSULTATION NOTED: THE PATIENT HAD THE ORIGINAL ICD IMPLANTED IN LATE (B)(6) 2010. AT THAT TIME, THE PATIENT HAD A CLASS III SYSTOLIC CONGESTIVE HEART FAILURE WITH AN EJECTION FRACTION OF 25% AND PROLONGED QRS DURATION. SINCE THAT TIME, THE PATIENT HAS DONE WELL, BUT ON RECENT ANALYSIS, THE DEVICE HAD REACHED THE ELECTIVE REPLACEMENT INDICATOR (ERI) AND HAD A HIGH LEFT VENTRICULAR PACING THRESHOLD OF GREATER THAN 5 VOLTS WITH A LOW IMPEDANCE OF LESS THAN 200 OHMS. THIS WAS PRESUMPTIVE EVIDENCE OF A CORONARY SINUS/LEFT VENTRICULAR LEAD FRACTURE. THE PATIENT WAS REFERRED FOR GENERATOR CHANGE AND SURGICAL MANAGEMENT OF HIS LEADS. NOTES FROM THE OPERATIVE REPORT: "THE IMPLANTING INCISIONAL SCAR IN THE LEFT ANTERIOR CHEST WALL WAS ELLIPTICALLY EXCISED AND THE INCISION CARRIED DOWN TO ENTER THE ICD POCKET. THERE WERE DENSE ADHESIONS AROUND THE LEADS INCORPORATING THE REMAINDER OF THE FIBROUS CAPSULE. THE LEADS WERE MOBILIZED AND CONSIDERABLE PORTION OF THE FIBROUS CAPSULE ESPECIALLY IN THE CEPHALAD PORTIONS OF THE POCKET AND THE POSTERIOR WALL OF THE CAPSULE WERE EXCISED. THE LEFT VENTRICULAR LEAD WAS EXAMINED AND APPEARED TO BE NORMAL THROUGHOUT ITS COURSE. ON FLUOROSCOPIC EXAMINATION, IT WAS DIFFICULT TO IDENTIFY ALONG ITS ENTIRE LENGTH BECAUSE OF BEING OBSCURED BY LARGER DEFIBRILLATOR LEAD WITH COILS PRESENT. NEVERTHELESS, THIS LEAD MEASURED INDEPENDENT OF THE CONNECTIONS TO THE HEADER OF THE DEVICE SHOWED HIGH PACING THRESHOLD OF GREATER THAN 5 VOLTS AND A VERY LOW IMPEDANCE OF LESS THAN 200 OHMS, SUGGESTING THAT THE LEAD WAS FRACTURED SOMEWHERE ALONG ITS COURSE."... AN ATTEMPT WAS MADE TO EXTRACT THE LEFT VENTRICULAR CORONARY SINUS ELECTRODE UNDER FLUOROSCOPIC GUIDANCE WITH GENTLE TRACTION ON THE LEAD, ONLY. THIS WAS UNSUCCESSFUL. ACCORDINGLY, THE LEAD WAS AMPUTATED AND A LASER LOCKING STYLET PASSED DOWN ITS COURSE. AN EXCIMER LASER WAS MOBILIZED AND THE LEAD WAS REMOVED IN ITS ENTIRETY. THE LEAD DID BEGIN TO UNRAVEL BUT THIS DID NOT PRESENT ANY SIGNIFICANT PROBLEMS IN EXTRACTING THE ENTIRE LEAD WITHOUT COMPLICATION." THE PATIENT TOLERATED THE PROCEDURE WELL, WITH NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42063 ATTAIN SELECT II DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MEDTRONIC, INC. 4196

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR