BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3093252 · Received May 5, 2013

    Report

    Report Number
    3004209178-2013-07322
    Event Type
    Malfunction
    Date Received
    May 5, 2013
    Report Date
    April 5, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 10642, LOT # J1105884R, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED SYS MOD WAS PERFORMED ON (B)(6) 2013. THE PUMP HAD NOT MOVED FROM THE ORIGINAL LOCATION, AS ORIGINALLY THOUGHT. ALL 4 SUTURES WERE STILL CONNECTED AND NEEDED TO BE CUT DURING THE PROCEDURE. THE PUMP WAS REPOSITIONED ONLY BECAUSE IT NEEDED TO BE TAKEN OUT OF THE POCKET TO CHANGE OUT THE CONNECTOR. IT WAS PLACED BACK IN ON THE LEFT SIDE (ORIGINAL LOCATION). CULTURES WERE DONE OF THE FLUID SEEN IN THE POCKET WITH RESULTS PENDING. IT WAS LATER REPORTED THE CULTURES FROM THE PATIENT¿S PUMP POCKET CAME BACK POSITIVE FROM TWO SEPARATE SPECIMENS GROWING (B)(6). IT WAS LATER REPORTED THERE WAS A SUSPECTED REMODULIN LEAK IN THE POCKET FROM THE SUTURE LESS CONNECTOR ALONG WITH SWELLING, REDNESS AND PAIN. THE CATHETER PASSED PATENCY AND PRESSURE TESTING. THERE WAS A NON-SIGNIFICANT INDENT SEEN DOWN IN THE CUP OF THE SC CONNECTOR WHICH DID NOT AFFECT DEVICE FUNCTION. BOTH RETAINING RING FINGERS DID NOT HAVE ANY SIGNIFICANT INDENTS, WHICH POSSIBLY INDICATES THE SC CONNECTOR WAS PROPERLY ALIGNED WHILE ATTACHED TO THE OUTLET PORT OF THE PUMP.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(4) 2012, THE AREA OF ERYTHEMA NOTED ON (B)(6) 2012 APPEARED TO BE LARGER. THE ITCHINESS CONTINUED. MULTIPLE DIFFERENTIAL DIAGNOSES SUGGESTED A GENERAL HEALING REACTION THAT WAS EXAGGERATED IN SUBJECT RECEIVING IV TREPROSTINIL; A TREPROSTINIL LEAK FROM PUMP; A LOCAL INFECTION; AND/OR EARLY SHINGLES. AN ABDOMINAL PA AND LATERAL X-RAY OF PUMP SITE REVEALED THE SYNCHROMED II SYSTEM APPEARED INTACT. ON (B)(6) 2012, THE DIAGNOSIS WAS UPDATED TO "POSSIBLE CONTACT DERMATITIS." THE SUBJECT CONTINUED TO HAVE PATCHES OF ERYTHEMA OVER THE PUMP POCKET AS WELL AS ITCHING. AN INFORMAL DERMATOLOGY CONSULT RULED OUT SHINGLES. POSSIBLE MORPHEA WAS SUSPECTED. AN ABDOMINAL CT AND ULTRASOUND REVEALED ONLY A TRACE AMOUNT OF SOFT TISSUE STRANDING WAS PRESENT ABOUT THE PUMP WITH NO FOCAL FLUID COLLECTION IDENTIFIED WITH CT IMAGING. NO ABNORMAL FLUID COLLECTIONS WERE NOTED, AND THE PATIENT WAS TO UNDERGO SKIN PATCH TESTING. ON (B)(6) 2012, THE SUBJECT REPORTED FOR REFILL VISIT #2. THE ERYTHEMA AND ITCHING OVER THE PUMP SITE CONTINUED. THE AREA WAS NOW WARM TO THE TOUCH. THE PATIENT STILL DENIED FEVER OR CHILLS. A DERMATOLOGY CONSULT INDICATED THERE IS NO EVIDENCE OF SCALE; ONLY ERYTHEMA OF THE SKIN. IT WAS MAINLY DERMAL WITHOUT ANY EPIDERMAL COMPONENT. EXAMINATION OF THE PATIENT REVEALED SHE HAD NUMEROUS, SILVER COLORED EARRINGS AS WELL AS A SILVER COLORED RING ON THE UMBILICUS. THE PATIENT HAD HAD NO REACTION TO ANY OF THESE RINGS WHICH ALL PRESUMABLY CONTAINED NICKEL. SHE WAS NOTED TO HAVE BROKEN OUT ONCE UNDERNEATH A GOLDEN BRACELET. PUNCH BIOPSY RESULTS REVEALED PERIVASCULAR LYMPHOCYTIC INFLAMMATION WITH PERIVASCULAR AND INTERSTITIAL EOSINOPHILS, CONSISTENT WITH URTICARIAL TISSUE REACTION. THERE WERE NO EPIDERMAL CHANGES. A POSSIBLE HYPERSENSITIVITY REACTION WAS SUSPECTED. TRIAMCINOLONE CREAM ADDED TO TREATMENT ALONG WITH WET DRESSINGS TO THE AREA. ON (B)(6) 2013, THE DIAGNOSIS WAS UPDATED TO SUBCUTANEOUS TREPROSTINIL DOSING. THE PUMP AND CATHETER LEAK WERE RULED OUT. THE PATIENT REPORTED FOR REFILL #3, AND THEIR ERYTHEMA APPEARED MORE BLOTCHY. ITCHING CONTINUED, AND THE SITE REMAINED WARM TO TOUCH. PUMP INTERROGATION REMAINED NORMAL. FLUOROSCOPY OF PUMP IMPLANT SITE REVEALED THE PUMP AND CATHETER CONNECTIONS WERE INTACT. A SKIN PATCH TESTING FOR METALS WAS NEGATIVE. THE PATIENT CONTINUED TO USE TRIAMCINOLONE CREAM, BUT WET DRESSINGS WERE DISCONTINUED. THE SITE NOTED THEY WOULD CONTINUE TO FOLLOW THE PATIENT. ON (B)(6) 2013, THE SITE NOTED THAT THE SUBJECT CONTINUES TO HAVE ERYTHEMA AND ITCHING OVER THE PUMP POCKET SITE, HOWEVER, THE SYMPTOMS WERE DECREASING. THE ERYTHEMA APPEARED LESS AND THE ITCHING WAS MORE INTERMITTENT. SWELLING WAS UNCHANGED FROM THE LAST REFILL VISIT ON (B)(6) 2013. PAIN CONTINUED OVER PUMP POCKET, THOUGH THE PATIENT REPORTED THERE WAS NO LONGER GENERALIZED PAIN, JUST ACUTE PAIN IF PUMP SITE IS "BUMPED". THIS PAIN WAS RATED UP TO A 5/10. THE SITE NOTED THEY WOULD CONTINUE TO ASSESS. IT WAS LATER REPORTED THAT THE PATIENT HAD AN INCREASE IN PAIN SINCE (B)(6) 2013 AND REQUESTED PAIN MEDS SINCE THE PAIN WAS IMPACTING DAY TO DAY ACTIVITIES (WORK AND SLEEP). SUBJECT REPORTED FOR 4TH REFILL VISIT ON (B)(6) 2013. THE PATIENT WAS REPORTING DECREASE IN PAIN. RATING 1 OUT OF 10 AT REST AND REPORTS HAS NOT HAD TO TAKE PAIN MEDICATION "FOR A COUPLE OF DAYS." PUMP SITE SWELLING HAS INCREASED SINCE SUBJECT WAS SEEN (B)(6) 2013 (6 MONTH VISIT). THE PUMP ALSO APPEARS TO HAVE MIGRATED LATERALLY. MEDTRONIC STUDY TEAM WORKING WITH SITE TO EXPLORE SYS MOD OPTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195938 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1