BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3132412 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08287
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 10, 2013
    Report Date
    May 28, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8711, LOT# J10854R10, IMPLANTED: (B)(6) 2001. PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MULTIPLE MOTOR STALLS WERE SEEN WITH RECOVERIES IN THE PUMP LOGS. THE MOTOR STALLS HAD OCCURRED PERIODICALLY STARTING, BUT COULDN¿T BE ATTRIBUTED TO ANY ENVIRONMENTAL FACTOR AS THE PATIENT WAS ¿PRETTY MUCH HOMEBOUND¿. THE PUMP WAS PROBABLY GOING TO REMAIN IN THE PATIENT DUE TO ISSUES WITH INSURANCE, THOUGH IT WAS STATED THAT, LONG-TERM, THE PUMP WOULD BE IDEALLY EXPLANTED. AT THE TIME OF REPORT, THE HEALTHCARE PROFESSIONAL WAS TURNING THE PUMP OFF PERMANENTLY. THE PATIENT WAS BEING MANAGED IN TERMS OF MEDICATION, THOUGH NO FURTHER DETAILS WERE GIVEN. THE DEVICE SYSTEM HAD BEEN DELIVERING DILAUDID AND BUPIVACAINE. THREE WEEKS LATER, IT WAS REPORTED THAT THE MOTOR STALL HAD NOT RECOVERED AND THE CAUSE OF THE MOTOR STALL WAS UNKNOWN. THE PATIENT HAD EXPERIENCED SOME WITHDRAWAL SYMPTOMS, THOUGH NO HOSPITALIZATION WAS REQUIRED. IT WAS ALSO REPORTED THAT THE PATIENT RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE STALLS HAD OCCURRED STARTING ON (B)(6) AND CONTINUED UNTIL THE PUMP WAS TURNED OFF ON (B)(6). THE PATIENT HAD EXPERIENCED WITHDRAWAL WITH NAUSEA, VOMITING, DIARRHEA, AND INCREASED PAIN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED ACUTE WITHDRAWAL. IT WAS NOTED THAT HOSPITALIZATION WAS REQUIRED AND IT WAS ALSO NOTED THAT THE PATIENT HAD AN EMERGENCY ROOM VISIT. IT WAS UNCLEAR IF THE REPORTER WAS SPECIFYING THAT THESE WERE THE SAME INSTANCE. THE EVENT WAS REPORTED AS A ¿SERIOUS INJURY/ILLNESS¿, THOUGH THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236933 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Hospitalization