BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2574408 · Received May 15, 2012

    Report

    Report Number
    3004209178-2012-03285
    Event Type
    Injury
    Date Received
    May 15, 2012
    Report Date
    April 17, 2012
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER MODEL: 8731SC, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), EXPLANTED: UNK; CATHETER MODEL: 8598A, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: UNK; CATHETER MODEL: 8590-1, LOT# N245547, IMPLANTED: 2010 (B)(6), EXPLANTED: UNK. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD CATHETER REVISION ON (B)(6) 2011 AND X-RAYS WERE PERFORMED (DETAILS NOT PROVIDED). IT WAS ADDED THAT PATIENT HAD X-RAYS TAKEN AGAIN ABOUT 2 WEEKS AGO FROM THE DATE OF THIS REPORT, AT "CATHETER SITE TO INTRATHECAL SPACE" AND TOLD "ALL LOOKS GOOD"; PATIENT HAD CONCERNS ABOUT PUMP TO CATHETER CONNECTION. SINCE (B)(6) 2012 PATIENT COMPLAINED OF A WARM SENSATION IN HER BUTTOCKS AREA THAT WENT DOWN HER LEG AFTER SHE GAVE HERSELF A BOLUS; IT WAS LATER ADDED THAT THE WARMTH WAS AT THE PUMP SITE. PATIENT HAD STOPPED USING THE PTM (PERSONAL THERAPY MANAGER) AND "THE NURSE AT THE CLINIC TOOK THE PTM FROM HER". IT WAS ADDED THAT SINCE DISCONTINUING THE BOLUSES PATIENT NO LONGER FELT WARMTH AT PUMP SITE. ABOUT THREE WEEKS AGO FROM THE DATE OF THIS REPORT IT WAS STATED THAT PATIENT'S PUMP INFUSION DRUG DILAUDID WAS DECREASED AS SHE WAS ON THE MAXIMUM DOSE AND BUPIVACAINE WAS INCREASED. PATIENT HADN'T NOTICED ANY IMPROVEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD AN X-RAY DONE 14 MONTHS FOLLOWING THE DEVICE IMPLANT, AND THE CATHETER WAS FOUND KINKED, COILED AND DISCONNECTED FROM THE PUMP. IT WAS ALSO REPORTED THAT WHENEVER THE PATIENT GAVE HERSELF A BOLUS, SHE WOULD GET NUMB AROUND THE PUMP SITE. THE PATIENT BELIEVED THAT THE PUMP WAS ¿LEAKING OUT A LITTLE BIT.¿

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT HAD ¿NOTHING BUT PROBLEMS¿ SINCE HER PUMP WAS IMPLANTED. THE ¿PROBLEMS¿ WERE CLARIFIED. BEFORE THE PUMP IMPLANT, THE HEALTHCARE PROVIDER (HCP) TOLD THE PATIENT WAS TOLD THAT HE WOULD PUT THE PUMP IN HER ¿BELLY SECTION¿. WHEN THE PATIENT WAS GOING TO SURGERY AND ALREADY SEDATED, THE NURSE TOLD THE PATIENT THAT THE HCP WAS GOING TO IMPLANT IT IN THE BACK. THE PATIENT HAD ALREADY HAD ¿VALIUM OR SOMETHING¿. WHEN ASKED WHAT MEDICATION WAS IN THE PUMP, THE REPORTER STATED THAT THE PATIENT HAD ¿BEEN THROUGH EVERYTHING¿. THE PATIENT¿S NEXT ¿ALARM DATE¿ WAS (B)(6).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER INDICATED THAT THE CATHETER WAS IN PLACE PER X-RAY; PATIENT HAD COMPLAINED OF NO PAIN RELIEF, WAS WITHOUT INJURY. INFUSION DRUG DOSES WERE INDICATED AS FOLLOWING DILAUDID 4 MG/DAY AND BUPIVICAINE 8 MG/DAY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention