BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3203634 · Received July 3, 2013

    Report

    Report Number
    6000030-2013-00174
    Event Type
    Injury
    Date Received
    July 3, 2013
    Report Date
    June 11, 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
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8703W, SERIAL# (B)(4), IMPLANTED: 1998-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT¿S NEWEST PUMP INDICATED ERI WAS IN TWENTY-FIVE MONTHS. WHEN TOLD IT WOULD BEGIN TO ALARM AT THAT POINT, THE PATIENT STATED THAT ¿IT DID THAT BEFORE AND THEY GOT REALLY SICK¿. THEY WANTED TO BE SURE SO THEY COULD SCHEDULE A MONTH AHEAD SO ¿THEY COULD GET IN THERE AND NOT GET SICK¿. THE PATIENT NOTED THEIR PUMP LASTED FOUR YEARS, THOUGH PER THE MANUFACTURER¿S DEVICE REGISTRY IT WAS IMPLANTED FOR ABOUT FIVE AND A HALF YEARS (65 MONTHS). THE MEDICATION USED WITHIN THE SYSTEM WAS UNKNOWN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD NEVER BEEN ABLE TO HEAR HER ALARM AND ¿THE FIRST TIME¿ HER PUMP RAN OUT SHE ¿GOT REAL SICK¿ AND DIDN¿T KNOW IT HAD BEEN ¿OUT¿ FOR 3-4 DAYS. THE SECOND TIME WHEN SHE WENT TO GET A REFILL ¿THEY FOUND IT.¿ IT WAS UNCLEAR IF THIS WAS ONE OR TWO OCCURRENCES OF EMPTY RESERVOIR BUT IT WAS NOTED THAT IT HAPPENED WHEN SHE ¿HAD THE VERY FIRST ONE PUT IN.¿ IT WAS NOTED THAT THE DEVICE ¿ONLY LASTED 3 YEARS.¿ THE DRUG INFUSED A THE TIME OF THIS EVENT WAS NOT KNOWN. UNABLE TO FOLLOW-UP WITH CONTACT INFORMATION PROVIDED, NO ADDITIONAL INFORMATION WAS OBTAINED.

    Description of Event or Problem · 1

    PREVIOUSLY REPORTED INFORMATION (ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD NEVER BEEN ABLE TO HEAR HER ALARM AND ¿THE FIRST TIME¿ HER PUMP RAN OUT SHE ¿GOT REAL SICK¿ AND DIDN¿T KNOW IT HAD BEEN ¿OUT¿ FOR 3-4 DAYS. THE SECOND TIME WHEN SHE WENT TO GET A REFILL ¿THEY FOUND IT.¿ IT WAS UNCLEAR IF THIS WAS ONE OR TWO OCCURRENCES OF EMPTY RESERVOIR BUT IT WAS NOTED THAT IT HAPPENED WHEN SHE ¿HAD THE VERY FIRST ONE PUT IN.¿ IT WAS NOTED THAT THE DEVICE ¿ONLY LASTED 3 YEARS.¿ THE DRUG INFUSED A THE TIME OF THIS EVENT WAS NOT KNOWN. UNABLE TO FOLLOW-UP WITH CONTACT INFORMATION PROVIDED, NO ADDITIONAL INFORMATION WAS OBTAINED.) WAS REPORTED IN ERROR, AND APPLIES TO MANUFACTURER REPORT 3004209178-2013-15178. THE CORRECT ADDITIONAL INFORMATION FOR THIS EVENT WAS RECEIVED AND REPORTED THAT THE PATIENT WAS GOING IN FOR A REPLACEMENT PUMP THE NEXT DAY, (B)(6) 2013, AND THAT HER ¿SHEET¿ SAID 23 MONTHS. IT WAS ALSO NOTED THAT SHE WAS TOLD THAT HER PUMP WAS ¿GOING TO EXPIRE IN AUGUST OR SEPTEMBER OF THIS YEAR¿ IT WAS NOT CLEAR WHO TOLD THE PATIENT THAT. IT WAS THEN STATED BY THE REPORTER ¿MAYBE SHE MISUNDERSTOOD.¿ THE PATIENT WAS AFRAID OF THE PUMP STOPPING AND THAT SHE HAD ¿NEVER¿ BEEN ABLE TO HEAR THE ALARM AND THAT SHE DIDN¿T WANT TO REPLACE THE PUMP IF SHE DIDN¿T NEED TO. THE DEVICE SYSTEM WAS USED TO INFUSE DILAUDID. UNABLE TO FOLLOW-UP WITH CONTACT INFORMATION PROVIDED, NO ADDITIONAL INFORMATION WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304333 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention