BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3150753 · Received June 6, 2013

    Report

    Report Number
    3004209178-2013-08751
    Event Type
    Injury
    Date Received
    June 6, 2013
    Report Date
    May 13, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8578, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY; PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE CATHETER; PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8578, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE CATHETER REVISION AND REPLACEMENT PROCEDURE WAS DUE TO A SUSPECTED OCCLUSION. THE ROLLER STUDY WAS PERFORMED TO CONFIRM PUMP OPERATIONAL STATUS, AS THE PATIENT WAS NOT GETTING GOOD RELIEF. THE SYMPTOMS THE PATIENT HAD WERE LACK OF PAIN CONTROL. THE PATIENTS CURRENT STATUS WAS UNKNOWN TO THE REPORTER. PLEASE SEE MANUFACTURER REPORT #3004209178-2013-04137 FOR INFORMATION RELATED TO LACK OF RELIEF PRIOR TO CATHETER REVISION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS ¿AN ISSUE¿, BUT THERE WERE NO DETAILS OF WHAT THE ISSUE WAS OR ANY TIMELINES KNOWN TO THE REPORTER, OTHER THAN PLANNED TROUBLESHOOTING OF A ROLLER STUDY. DRUG DELIVERED VIA THE DEVICE WAS MORPHINE. IT WAS LATER REPORTED THAT ON (B)(6) 2013 THERE WAS A CATHETER REVISION, WITH THE REASON FOR REVISION NOT PROVIDED. PRIOR TO BEGINNING THE REVISION, IT WAS BELIEVED BY THE REPORTER THAT THE HEALTHCARE PROVIDER (HCP) WAS GOING TO PROCEED WITH A CATHETER DYE STUDY, AS THERE WAS A REQUEST TO OPEN A CATHETER ACESS PORT (CAP) KIT. THE HCP BEGAN PREPPING THE PATIENT, OPENED THE POCKET TO DISCONNECT THE PUMP SEGMENT AND REMOVE THE PUMP, AND INDICATED ALREADY HAVING DONE DIAGNOSTIC TESTING PREVIOUSLY WHEN IT WAS INQUIRED IF THE HCP WAS GOING TO BEGIN ¿PUSHING DYE¿ FOR THE STUDY. THE HCP ¿VERY BRIEFLY¿ BROUGHT IN THE FLUOROSCOPE TO LOCATE THE DISTAL END OF THE CATHETER, WITHOUT IDENTIFYING THE LOCATION OF THE ANCHOR. THE HCP PROCEEDED TO PUT TENSION ON THE CATHETER FROM THE PUMP POCKET TO SEE IF THERE WAS ANY RESISTANCE, WHICH THERE WAS NOT. THE HCP WAS THEN UNDER THE IMPRESSION THAT THE CATHETER WAS IN THE SOFT TISSUE AND WANTED TO DISSECT THE SPINAL INCISION AND LOOK FOR THE ANCHOR, SO THE HCP THEN DISMISSED THE RADIOLOGY TECH FROM THE PROCEDURE. IT WAS THEN NOTED THAT THE HCP DECIDED TO MOVE FORWARD WITHOUT LOCATING THE ANCHOR, WHICH WAS RADIOPAQUE, VIA FLUOROSCOPY. THE HCP THEN SPENT APPROXIMATELY 90 MINUTES DISSECTING THE ISSUE AND WAS ULTIMATELY UNABLE TO LOCATE THE ANCHOR. THERE WAS A SIGNIFICANT AMOUNT OF BLOOD LOSS WHICH RESULTED IN THE HCP DECISION TO ABANDON THE ANCHOR AND REMOVE THE CATHETER THROUGH THE POCKET. THE HCP THEN GAINED ACCESS TO THE INTRATHECAL SPACE AND INSERTED THE DISTAL END OF THE CATHETER. THE HCP REMOVED THE NEEDLE AND REQUESTED THAT THE SCRUB TECH FEED THE ANCHORING DEVICE ONTO THE CATHETER. DUE TO A SEVERE TREMOR, HE WAS UNABLE TO HOLD OR DEPLOY THE ANCHORING DEVICE PROPERLY; THUS THE SCRUB TECH COMPLETED THIS AS WELL. THE HCP HAD YET TO ACHIEVE HEMOSTASIS AND THERE WAS STILL A SIGNIFICANT AMOUNT OF BLOOD COMING FROM THE WOUND, DESPITE ATTEMPTS TO CAUTERIZE THE TISSUE. WITH THE CATHETER EXPOSED, THE HCP PROCEEDED TO SUTURE MULTIPLE LAYERS OF TISSUE TOGETHER REPEATEDLY, ENTANGLING THE CATHETER AND THE SUTURE STRING MULTIPLE TIMES, NEGLECTING TO TUNNEL AND PROTECT THE CATHETER. EVENTUALLY THE CATHETER WAS TUNNELED TO THE POCKET AND CONNECTED TO THE PUMP. THE HCP STRUGGLED TO FIT THE PUMP IN ITS EXISTING POCKET, AS THE CATHETER WAS BECOMING COILED AROUND THE BODY OF THE PUMP IN FRONT OF THE RESERVOIR PORT. PER THE REPORTER, THE HCP WAS ASKED TO TUCK THE CATHETER BEHIND THE PUMP, BUT RESPONDED, ¿THEY CAN¿T ALL BE PERFECT, THE CATHETER IS GOING TO DO WHAT IT WANTS TO DO.¿ THE HCP WAS FURTHER ASKED TO UNDO THE SUTURED LOOPS THAT WERE KEEPING THE CATHETER IN PLACE, AND THE HCP DECLINED AND CLOSED THE PUMP POCKET. IT WAS LATER REPORTED THAT THE HCP DID NOT FOLLOW SUGGESTED PROTOCOL FOR THE IMPLANT OF THE REPLACEMENT CATHETER DURING REVISION. THE REPORTER INDICATED THAT DUE TO THE SIGNIFICANT BLOOD LOSS AND LACK OF HEMOSTASIS DURING THE PROCEDURE, ADVERSE SYMPTOMS MAY HAVE BEEN SUBSEQUENTLY PRESENT, BUT WERE UNKNOWN TO THE PROVIDER. IN ADDITION THERE WAS A NOTED RISK OF PUNCTURED A CATHETER IN THE FUTURE DUE TO PROXIMITY TO RESERVOIR PORT. NO PATIENT SYMPTOMS WERE IDENTIFIED. THE CAUSE OF THE NEEDED REVISION WAS NOT PROVIDED BY THE REPORTER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251047 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention