BEUDAMED
    FDA Adverse Event Death Summary report: N

    BONE SCREW 76353200 REPOSE SYSTEM

    MDR report key: 2549109 · Received April 18, 2012

    Report

    Report Number
    1045254-2012-00177
    Event Type
    Death
    Date Received
    April 18, 2012
    Date of Event
    February 28, 2007
    Report Date
    April 12, 2007
    Manufacturer
    INFLUENT MEDICAL, LLC
    Product Code
    LRK
    PMA / PMN Number
    K981677
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASSETS OF INFLUENT MEDICAL, LLC, REGARDING THE REPOSE DEVICE, WERE PURCHASED BY MEDTRONIC XIOMED, INC. IN 2008. IN A SUBSEQUENT REVIEW OF INFLUENT MEDICAL'S COMPLAINT RECORDS OBTAINED DURING THE ACQUISITION, THIS EVENT WAS IDENTIFIED, AND (TO THE BEST OF OUR KNOWLEDGE) WAS FOUND NOT TO HAVE BEEN REPORTED TO THE FDA IN A MDR BY THE MFR. WHILE MEDTRONIC XIOMED DID NOT RETAIN THE LIABILITIES AND RESPONSIBILITIES OF INFLUENT MEDICAL FOR THE REPOSE DEVICES MFG BY THEM PRIOR TO THE ACQUISITION, WE FELT IT WAS APPROPRIATE TO SUBMIT THIS MEDICAL DEVICE REPORT. COMMENTS: PT ALSO HAD A SEPTOPLASTY AND A UVULOPALATOPHARYNGOPLASTY [UPPP] PERFORMED DURING THE SAME SURGERY AS THE GA/HS. THE DEVICES USED TO PERFORM THE SEPTOPLASTY AND UPPP ARE UNK. ACCORDING TO THE REPORTING PHYSICIAN, THE PT WAS GIVEN "4 (MG) OF MORPHINE AND TOO MUCH PHENERGAN." CLARIFICATION: THIS INFO WAS VALID AT THE TIME OF THE EVENT IN 2007, UNK IF ADDRESS AND PHONE NUMBER ARE STILL VALID. THE FOLLOWING IS BASED ON PHONE NOTES IDENTIFIED IN INFLUENT MEDICAL'S RECORDS TRANSFERRED TO MEDTRONIC XOMED DURING THE ACQUISITION PROCESS, AND INCLUDED NOTES ON A PHONE CALL BETWEEN (B)(6) AND DR (B)(6), (B)(6) 2007: ACCORDING TO DR (B)(6), IN THE POST MORTEM REPORT, THERE WAS NO EVIDENCE OF MI; THE CAUSE OF DEATH WAS MOST LIKELY PRIMARY RESPIRATORY ARREST. IN CONJUNCTION WITH SEDATION, SURGICAL AIRWAY SWELLING, AND A HISTORY OF OSA, THESE FACTORS PROVED TOO MUCH FOR MR.(XXXX). MR (B)(6) ASKED DR (B)(6) IF HE FELT THE REPOSE PROCEDURES WERE IN ANY WAY RESPONSIBLE FOR THE DEATH. AGAIN, ACCORDING TO DR (B)(6), THE CAUSE OF DEATH WAS NOT PRIMARILY DUE TO THE REPOSE DEVICE; BUT, WAS CERTAINLY PARTIALLY A RESULT OF SURGERY (SEPTOPLASTY, UPPP, GENIOGLOSSUS ADVANCEMENT AND HYOID SUSPENSION). SURGERY WAS A CONTRIBUTORY FACTOR BUT NOT THE ENTIRE CAUSE OF DEATH; MAYBE 15% OF THE FACTOR. SEVERE OSA WAS MOST LIKELY A KEY FACTOR, AS WAS THE QUALITY OF FLOOR NURSING CARE. IT SHOULD BE NOTED THAT THIS IS THE ONLY DEATH EVER REPORTED WITH ANY CONNECTION TO THE REPOSE BONE SCREW SYSTEM, EITHER BEFORE OR AFTER THE PRODUCT WAS ACQUIRED BY MEDTRONIC IN (B)(4) 2008.

    Description of Event or Problem · 1

    A PT EXPIRED 1 DAY AFTER SURGERY FOR SEVERE OBSTRUCTIVE SLEEP APNEA (SEPTOPLASTY, UVULOPALATOPHARYNGOPLASTY [UPPP], GENIOGLOSSUS ADVANCEMENT AND HYOID SUSPENSION [GA/HS]), AT THE BIRMINGHAM VA MED CTR. ACCORDING TO THE REPORTING PHYSICIAN, "CAUSE OF DEATH WAS MOST LIKELY PRIMARY RESPIRATORY ARREST." [THE REPOSE BONE SCREW SYSTEM OF INFLUENT MEDICAL WAS USED TO PERFORM THE GA/HS PROCEDURE. THE DEVICES USED TO PERFORM THE SEPTOPLASTY AND UPPP ARE UNK.]

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE SCREW 76353200 REPOSE SYSTEM LRK - DEVICE, ANTI-SNORING LRK INFLUENT MEDICAL, LLC 76353200 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death