BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3193390 · Received June 27, 2013

    Report

    Report Number
    3007566237-2013-02136
    Event Type
    Injury
    Date Received
    June 27, 2013
    Report Date
    June 3, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE PUMP MANUFACTURING INFORMATION HAS ADDITIONALLY CHANGED DUE TO THE UPDATE IN DEVICE IDENTIFICATION FOR THE EVENT. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT ALL OF THE ISSUES BEGAN ABOUT A WEEK BEFORE THE PUMP WAS DUE TO BE REFILLED. THERE WAS AN ALARM BUT, BUT THE PATIENT AND FAMILY WERE NOT SURE THEY HEARD ONE BECAUSE THEY ARE HARD OF HEARING. THE FIRST TIME THEY HEARD IT THEY WERE IN THE KITCHEN AND THOUGHT IT WAS A MICROWAVE OR OTHER APPLIANCE, AS THE PATIENT DID NOT KNOW THAT THE PUMP HAD AN ALARM. THE PATIENT¿S FAMILY INDICATED THEY WERE TOLD THAT THE PUMP HAD FAILED AND MALFUNCTIONED AND THEY WERE NOT TOLD IN WHAT WAY. THEY HAD TESTED IT AND THAT IT WAS TRUE, BUT THE REPORTER WAS UNSURE OF WHAT KIND OF TEST IT WAS. THE PATIENT HAD GONE FOR 2 OR 3 DAYS WITHOUT MEDICATION AND ENDED UP IN WITHDRAWAL AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT¿S FAMILY SATED THAT THE PAIN ALMOST KILLED THE PATIENT. THE REPORTER INDICATED THAT THEY TURNED THE DEVICE OFF AND THAT IT STARTED WORKING AGAIN ON ITS OWN; THIS IN TURN MADE THE PATIENT SICK AGAIN, AND THE PATIENT WAS ADMITTED AGAIN TO THE HOSPITAL. AS OF 7/09/2013 THE PUMP WAS TURNED OFF AND THE PATIENT WAS IN REHABILITATION. THE PATIENT HAD FENTANYL AND CLONIDINE IN THE PUMP AND THE PATIENT¿S PAIN WAS NOW BEING MANAGED BY A FENTANYL PATCH AND ORAL CLONIDINE. THE HEALTH CARE PROVIDER (HCP) DID NOT BELIEVE THE PATIENT WAS AS SICK AS SHE WAS, PER THE FAMILY, AND WOULD NOT ADMIT HER TO THE HOSPITAL SO THEY HAD TO CALL THEIR FAMILY PHYSICIAN AND HAVE HIM DO IT AS PREVIOUSLY REPORTED. THE PATIENT DID NOT WANT ANY FURTHER SURGERY, AS THE PATIENT WAS TOO WEAK AND DID NOT WANT TO TAKE THE RISK OF ANYTHING ELSE GOING WRONG, PER THE FAMILY. THE PATIENT WAS CURRENTLY EXPERIENCING A URINARY TRACT INFECTION (UTI) AND A STAPH/MRSA INFECTION WHICH WAS CAUGHT WHILE THE PATIENT WAS IN THE HOSPITAL, AS SHE WAS IN THE HOSPITAL FOR OVER A MONTH. THE FAMILY INDICATED THE PATIENT WILL NOT LIKELY WILL NOT LET THEM GIVE HER ANOTHER DEVICE, NOR WOULD SHE LIKELY LET THEM EXPLANT THE CURRENT PUMP EITHER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IN THE EMERGENCY ROOM FOR THE ENTIRE DAY AND SUBSEQUENTLY ADMITTED TO THE HOSPITAL ON THE DAY OF REPORT, DUE TO A PROBLEM RELATED TO THE PUMP. PER THE REPORTER, THE PATIENT¿S PAIN MANAGEMENT HEALTHCARE PROVIDER (HCP) HAD REFUSED TO SEE HER OR ADMIT THE PATIENT, AND THE PATIENT¿S PRIMARY HCP STEPPED IN TO DO SO. THE REPORTER STATED ¿IT SEEMS MAYBE THE MEDS RAN OUT TOO SOON..?¿ AND THE PATIENT WAS ¿IN AGONY¿. THE PATIENT¿S FAMILY NOTED DISSATISFACTION WITH THE PAIN HCP. NO FURTHER DETAILS WERE PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293754 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Hospitalization