BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3200094 · Received July 1, 2013

    Report

    Report Number
    3004209178-2013-11134
    Event Type
    Injury
    Date Received
    July 1, 2013
    Report Date
    June 6, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE 8703W CATHETER REVEALED A HOLE IN THE CATHETER BODY CAUSED BY A DEEP ABRASION. JUST 9CM OF THE PROXIMAL SEGMENT OF THE CATHETER WAS RETURNED ALONG WITH THE ANCHOR. AN AREA OF DEEP ABRASION AND HOLE WERE SEEN ON THE CATHETER BODY THAT WAS LIKELY DUE TO THE PATIENT ANATOMY.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8703W, LOT# L56474, IMPLANTED: (B)(6) 1998, PRODUCT TYPE CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE REMAINING THREE PIECES OF THE CATHETER WERE RETURNED. ANALYSIS OF THESE PORTIONS FURTHER REVEALED THAT THE CATHETER BODY HAD A HOLE OR TEAR THAT WAS CAUSED BY THE CATHETER CONNECTOR PIN.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE EXPERIENCED SOME MILD WITHDRAWAL SYMPTOMS AND HAD A ¿KNOT¿ ON HER BACK. A DYE STUDY WAS ATTEMPTED BUT THE HCP WAS UNABLE TO ASPIRATE AND THE CATHETER WAS REPLACED. IT WAS LATER REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM (ER) ON THE MORNING OF (B)(6) 2013 FOR UNCONTROLLED RIGHT LEG PAIN. THE PATIENT HAD AN MRI AT APPROXIMATELY 2:00 ON THAT DAY AND THE PUMP WAS TO BE INTERROGATED FOLLOWING THE MRI.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A SORE SPOT AT THE CATHETER ENTRY SITE POSSIBLY WITH FLUID OR SCAR TISSUE GATHERING AT THE SAME SITE. THE PATIENT HAD PAIN IN THE BACK WITH SURFACE TYPE PAIN JUST UNDER THE SKIN, ¿POSSIBLY CATHETER OR ANCHOR¿. THE HEALTHCARE PROVIDER (HCP) STATED THAT AN X-RAY SEEMED TO VERIFY HIS DIAGNOSIS. THE PATIENT WAS NOT EXPERIENCING ANY THERAPEUTIC ISSUES WITH PAIN RELIEF OR WITHDRAWAL. THE HCP WAS TO SCHEDULE SURGICAL EXPLORATION OF THE CATHETER; HOWEVER, A DATE WAS NOT YET SCHEDULED. IT WAS LATER REPORTED THAT THE CATHETER WAS REVISED. THE HCP CUT OUT APPROXIMATELY 9CM THAT SEEMED TO BE ¿BUNCHED UP¿ TOGETHER AROUND THE ¿HORSESHOE ANCHOR¿. THE HCP USED CAUTERY FOR MOST OF THE REVISION, SO WHAT HE CALLED ¿VERTICAL SHEARING¿ OR ¿VERTICAL TEARS¿ IN THE CATHETER WERE DEEMED TO BE THERE PREVIOUS TO HIS INCISION FOR THE CATHETER REVISION. THE HCP ¿DID NOT OBSERVE MUCH CEREBROSPINAL FLUID (CSF)¿ AT THE INCISION SITE, AND DID NOT CLAIM TO SEE CSF OR DRUG BACKING OUT OF THE PROXIMAL OR SPINAL PORTIONS OF THE CATHETER. THE HCP RE-CONNECTED THE CATHETER WITH A CONNECTOR PIN. THE HCP ORDERED THE PATIENT¿S DOSE TO BE DECREASED FROM 13.5MG/DAY TO 7MG/DAY AND KEEP THE PATIENT IN THE HOSPITAL OVERNIGHT FOR OBSERVATION. THE HCP ORDERED THE PATIENT TO BE OBSERVED FOR SIGNS OF WITHDRAWAL OR OVERDOSE; HOWEVER, THE PATIENT DID NOT SHOW ANY SIGNS OF WITHDRAWAL, ONLY PAIN AT THE SITE WHERE THE SURGERY WAS DONE TO EXCISE A PORTION OF THE CATHETER. THE DEVICE SYSTEM DELIVERED DILAUDID 25MG/ML. IT WAS LATER REPORTED THAT THE FRACTURED SECTION OF THE CATHETER WAS RETURNED TO THE MANUFACTURER. IT WAS LATER REPORTED THAT THE PATIENT WAS ¿DOING WELL¿ POST CATHETER REVISION.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE HCP WAS DO PERFORM A CATHETER DYE STUDY ON (B)(6 2013. PER THE NURSE, THE PATIENT EXPERIENCED SOME HALLUCINATIONS. THE HCP PUT THE PATIENT ON SOME ORAL BACLOFEN AND BELIEVED THE SYMPTOMS MAY HAVE BEEN FROM WITHDRAWAL AS THE PATIENT WAS WEANED FROM THE ORAL DOSE; HOWEVER, THE HCP WAS GOING TO CHECK THE CATHETER ANYWAY.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT HAD A MASS AT THE LUMBAR SPINE. IT WAS LATER REPORTED THAT A ¿SEROMA¿ HAD REAPPEARED IN THE SAME PLACE THAT THE SURGERY TOOK PLACE, VIA THE ORIGINAL SEROMA. A CATHETER DYE STUDY WAS TO BE PERFORMED ON 2013-(B)(6) TO CHECK FOR A POSSIBLE LEAK. IT WAS LATER REPORTED THAT THE HCP WAS UNABLE TO ASPIRATE THE CATHETER THROUGH THE CATHETER ACCESS PORT (CAP). THE PATIENT DID NOT SHOW ANY SIGNS OF WITHDRAWAL OR OVERDOSE. NO INTERVENTION WAS PLANNED AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298247 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R