BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIGIS-R LARGE

    MDR report key: 5421944 · Received February 9, 2016

    Report

    Report Number
    3005619263-2016-00001
    Event Type
    Malfunction
    Date Received
    February 9, 2016
    Date of Event
    September 24, 2015
    Report Date
    November 30, 2015
    Manufacturer
    TYRX, INC.
    Product Code
    FTL
    PMA / PMN Number
    K130943
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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).

    Additional Manufacturer Narrative · 1

    ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS THE PHYSICIAN WAS CLOSING THE POCKET FOLLOWING LEAD IMPLANT, THE ATRIAL LEAD DISLODGED. THE PHYSICIAN ATTEMPTED TO REPOSITION THE LEAD BUT THE PACING THRESHOLD NEVER IMPROVED. THE PHYSICIAN BELIEVED THERE WAS DIFFICULTY EXTENDING AND RETRACTING THE HELIX. THE STUDY INVESTIGATOR NOTED THAT THE EVENT WAS RELATED TO THE PROCEDURE AND THE ATRIAL LEAD. THE LEAD WAS EXPLANTED AND REPLACED. IT WAS FURTHER REPORTED THAT THE PHYSICIAN WONDERED ABOUT THE ABSORBABLE ENVELOPE "GRABBING" THE LEADS WHEN PLACED IN THE POCKET CAUSING MICRO DISLODGEMENT AND THEN ATRIAL LEAD DISLODGEMENT WITH DEFIBRILLATION THRESHOLD (DFT) TESTING. THE PHYSICIAN THOUGHT PERHAPS THEY HAD PROBABLY TOO MUCH LEAD LENGTH IN POCKET, WRAPPED IMPLANTABLE PLUS GENERATOR (IPG) ONLY AND COULD SEE HOW IPG GOING IN COULD HAVE POTENTIALLY GRABBED PULLED THE LEAD. THE ABSORBABLE ENVELOPE WAS IMPLANTED. THE PATIENT WAS ENROLLED IN THE (B)(6) CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PHYSICIAN STRUGGLED WITH GETTING THE ENVELOPE INTO THE POCKET, AND SUGGESTED THAT IT WAS THE STRUGGLE WHICH CAUSED THE ATRIAL LEAD TO DISLODGE. PRIOR TO PLACING THE IPG WITH ENVELOPE INTO THE POCKET, THE ATRIAL LEAD HAD TESTED WITHIN NORMAL PARAMETERS THROUGH THE ANALYZER. AFTER PLACING THE IPG AND ENVELOPE IN THE POCKET IT SEEMED THAT THE ATRIAL LEAD WAS SENSING IN THE RIGHT VENTRICLE. FLUOROSCOPY WAS USED TO VERIFY DISLODGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81901 AIGIS-R LARGE MESH, SURGICAL, POLYMERIC FTL TYRX, INC. CMRM6133 15H27636

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR