BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3115641 · Received May 16, 2013

    Report

    Report Number
    3007566237-2013-01642
    Event Type
    Malfunction
    Date Received
    May 16, 2013
    Date of Event
    April 19, 2013
    Report Date
    July 15, 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

    CONCOMITANT PRODUCT: PRODUCT ID 8709, SERIAL# UNKNOWN, IMPLANTED: UNKNOWN, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8578, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE ACCESSORY; PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PUMP REPLACEMENT PROCEDURE THE HEALTH CARE PROFESSIONAL WAS UNABLE TO ASPIRATE FROM THE CATHETER WITH A 25 GAUGE NEEDLE AND A TUBERCULIN SYRINGE WHILE THE CATHETER WAS DISCONNECTED FROM THE PUMP. IT WAS NOTED THAT THE PATIENT HAD BEEN GETTING GOOD THERAPY PRIOR TO THE SURGERY. THE DRUG IN THE PUMP WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    THIS EVENT WAS ALSO REPORTED UNDER MANUFACTURER REPORT #3004209178-2013-11125 [IT WAS REPORTED THAT FOLLOWING A PUMP REPLACEMENT SURGERY (REFER TO MANUFACTURER REPORT # 6000030-2013-00171), DURING WHICH TIME THE HEALTH CARE PROVIDER (HCP) HAD TROUBLE ASPIRATING FROM THE CATHETER, THE HCP PUT THE PATIENT ON HALF THE DRUG DOSE IN THE NEW PUMP. A FEW DAYS LATER THE PATIENT RETURNED WITH WITHDRAWAL SYMPTOMS AND THE HCP ENDED UP REPLACING THE CATHETER ¿A FEW WEEKS AGO¿. IT WAS REPORTED THE PATIENT WAS ¿OKAY¿ NOW.]. ANY ADDITIONAL INFORMATION RECEIVED WILL BE REPORTED UNDER THIS MANUFACTURER REPORT NUMBER (#3007566237-2013-01642). IT WAS LATER CLARIFIED THAT THE SURGERY ON THE PUMP WITH UNSUCCESSFUL CATHETER ASPIRATION AND PATIENT NOT POSITIONED FOR CATHETER REVISION IN MANUFACTURER REPORT 6000030-2013-00171 OCCURRED ON (B)(6) 2013. THE PATIENT ¿WAS MISERABLE¿ WHEN SHE WENT IN TO SEE THE HEALTHCARE PROVIDER (HCP) ON (B)(6) 2013. SHE HAS NAUSEA AND VOMITING, WAS DEHYDRATED, IT WAS NOTED ¿ALL THE SYMPTOMS THAT YOU WOULD EXPECT TO SEE FROM WITHDRAWAL.¿ THE HCP INCREASED THE INFUSION RATE, NOTING ¿IT VIRTUALLY DID NO BETTER AT ALL.¿ THE PATIENT WAS SEEN AGAIN BY THE HCP ON (B)(6) 2013 AND ¿ACTUALLY THOUGHT SHE WAS BETTER BUT REALLY SHE WAS NOT¿ SO ¿ULTIMATELY¿ THE HCP TOOK HER BACK TO THE OPERATING ROOM AND REPLACED THE CATHETER ON (B)(6) 2013. IT WAS NOTED THAT PRIOR TO THE (B)(6) 2013 PUMP REMOVAL THE PATIENT WAS TAKING ¿AROUND¿ 6.65MG OR MORPHINE A DAY AND AFTER THE CATHETER WAS REPLACED ON (B)(6) 2013 THE INFUSION RATE WAS 0.125 MG OF MORPHINE AND 0.325 MG OF BUPIVACAINE. IT WAS NOTED THAT THE PATIENT WAS ¿BACK TO HER OLD SELF, WAS ¿DOING VERY WELL.¿ IT WAS STATED THAT IT APPEARED THAT THE CATHETER WAS OBSTRUCTED BUT IT WAS NOT DUE TO ANY KIND OF GRANULOMA.¿ THE HCP COULD NOT EXPLAIN WHY IT HAPPENED, BUT NOTED ONCE THE NEW CATHETER IN, THEY WERE ABLE TO TREAT THE PATIENT ¿AT ON TWENTIETH OF THE DOSE,¿ SO IT WAS SUSPECTED THAT THE CATHETER WAS DELIVERING THE DRUG EITHER SUBDURALLY BUT SHE WAS JUST NOT GETTING THE DRUG INTO THE SUBARACHNOID SPACE¿ IT WAS ALSO NOTED THAT SINCE THE HCP HAD NOT PUT THE ORIGINAL PUMP AND CATHETER IN HE ¿COULD NOT TELL.¿ IT WAS THEN STATED THAT THE CURRENT SYSTEM WAS DOING ¿WELL¿ AND THE PATIENT WAS ¿DELIGHTED WITH THE RESULTS.¿

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE HEALTH CARE PROVIDER ENDED UP GIVING HALF THE DOSE OF DRUG AND SENT THE PATIENT HOME. THE ISSUE WAS RESOLVED AND THE PATIENT WAS REPORTEDLY ¿FINE¿.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE REPORTER DIDNOT KNOW THE PATIENT¿S NAME, AS HE HEARD ABOUT THE EVENT ¿IN PASSING.¿ THE CATHETER WAS REVISED AND HE HEARD THAT THE PATIENT DID NOT HAVE FURTHER ISSUES. THE REPORTER ATTEMPTED TO CALL THE HEALTHCARE PROVIDER¿S OFFICE TO GET FURTHER INFORMATION BUT WAS UNABLE TOFIND OUT WHO THE PATIENT WAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217171 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention