BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3932731 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-12981
    Event Type
    Injury
    Date Received
    July 14, 2014
    Report Date
    June 17, 2014
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP, SERIAL NUMBER (B)(4), FOUND NO ANOMALY. ANALYSIS OF THE CATHETER, SERIAL NUMBER (B)(4), FOUND CATHETER CONNECTOR WITH A NON-SIGNIFICANT INDENT IN SEAL AND DID NOT AFFECT INFUSION. ANALYSIS OF CATHETER, SERIAL NUMBER (B)(4), FOUND CATHETER INCOMPLETE AND RETURNED IN SEGMENTS. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER; PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A RESERVOIR VOLUME DISCREPANCY. IT WAS NOTED THAT THE PATIENT¿S HEALTH CARE PROFESSIONAL (HCP) PULLED MOST OF THE RESERVOIR VOLUME OUT DURING REFILL. THE EXACT MAGNITUDE OF THE VOLUME DISCREPANCY WAS UNKNOWN AT THE TIME OF REPORT. THE PATIENT HAS NOT HAD PAIN RELIEF IN 6 MONTHS. THE ACTIONS REQUIRED AS A RESULT OF THE EVENT INCLUDED REPLACEMENT. DIAGNOSTIC TESTING INCLUDED A DYE STUDY AND CHECKING LOGS. IT WAS NOTED THAT THE PRODUCT ISSUE WAS RESOLVED. THE CAUSE OF THE ISSUE WAS NOT DETERMINED. THE PATIENT¿S STATUS AT THE TIME OF REPORT WAS ALIVE ¿ NO INJURY. PATIENT SYMPTOMS INCLUDED LESS THAN 50 % THERAPY RELIEF; THE LOCATION OF THE ISSUE OR SYMPTOMS WAS AT AN UNKNOWN LOCATION. THE PUMP WAS USED TO INFUSE FENTANYL. IT WAS LATER REPORTED THAT THE PATIENT¿S PUMP MALFUNCTIONED AND THE CATHETER MIGRATED WHICH RESULTED IN A NEW ENTIRE SYSTEM BEING IMPLANTED ON (B)(6) 2014. IT WAS LATER REPORTED THAT THE PUMP WENT BAD AND THE CATHETER WENT INTO THE PATIENT¿S NECK. THE PATIENT CLARIFIED THAT THE MEDICINE STOPPED COMING OUT OF THE RESERVOIR AND STATED THAT PART OF THE CATHETER DISLODGED AND WAS UP INTO THE PATIENT¿S NECK. IT WAS UNKNOWN HOW LONG THE MEDICATION STOPPED COMING OUT OF THE RESERVOIR, BUT IT WAS MINIMALLY 6 MONTHS BECAUSE THE MEDICATION PUT IN 6 MONTHS EARLIER WAS STILL IN THE RESERVOIR. IT WAS UNKNOWN IF THIS WAS THE PATIENT¿S FIRST VOLUME DISCREPANCY. IT WAS UNKNOWN IF THE PATIENT¿S HEALTH CARE PROFESSIONAL (HCP) REPLACED THE PUMP OR REPOSITIONED THE CATHETER. IT WAS REPORTED THAT THE PATIENT HAD A GRADUAL ONSET OF SYSTEMS AFTER A FALL. THE PATIENT REPORTEDLY BROKE THEIR FOOT IN AUGUST AND BROKE THEIR TIBIA AND DIDN¿T GET ANY PAIN RELIEF AND WAS IN SEVERE PAIN FOR 6 MONTHS. THE PATIENT¿S HCP DID A CATHETER DYE STUDY AND REALIZED THE CATHETER WAS IN THE PATIENT¿S NECK INSTEAD OF LOWER PART OF SPINE WHERE IT WAS SUPPOSED TO BE. THE PATIENT DID NOT KNOW HOW LONG THEY WEREN¿T GETTING ANY PAIN RELIEF. IT WAS REPORTED THAT IT WAS POSSIBLE WHEN THE PATIENT FELL THE PRIOR (B)(6) FROM THE STANDING POSITION THAT THEY DAMAGED THE CATHETER BECAUSE THE PATIENT BROKE THEIR TIBIA AND FEMUR AND NEEDED 16 PINS. THE PATIENT HAD AN APPOINTMENT ¿TO GET IT FIXED¿ ON (B)(6) 2014. THE PATIENT REPORTED AFTER THEIR LEG SURGERY FROM THEIR FALL, THEY ¿PICTURED¿ BEING OKAY WHEN THE ¿BLOCKS COME OFF AND WASN¿T OKAY UP UNTIL YESTERDAY¿. THE PATIENT REPORTEDLY NEVER HAD 100% PAIN RELIEF SINCE IMPLANT BUT DID HAVE A VARIANCE OF 20%. IT WAS NOTE THAT ¿IT HELPED AT THAT TIME¿. THE PATIENT REPORTED THAT THEY STILL HAD TO TAKE PAIN PILLS. THE PATIENT WAS DOWN TO NOT TAKING PILLS EXCEPT ONCE ¿EVERY BLUE MOON¿ AND THE PATIENT FELT THAT THEY WEREN¿T GOING TO BE PAIN FREE. PER LOGS RECEIVED, A MOTOR STALL OCCURRED ON (B)(6) 2014 AT 10:45 AND A MOTOR STALL RECOVERY OCCURRED (B)(6) 2014 AT 11:20.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT RECEIVING FENTANYL (5000MCG/ML, 450MCG/DAY) VIA AN IMPLANTABLE INFUSION PUMP. THE PATIENT REPORTED THAT A DYE STUDY HAD REVEALED THAT THE CATHETER WAS KINKED AND THE TIP HAD MOVED UP HER SPINE TO HER NECK (AS PREVIOUSLY REPORTED). THE PUMP AND CATHETER WERE REPLACED IN 2014 BECAUSE OF THIS INCIDENT (AS PREVIOUSLY REPORTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409405 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention