BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2250728 · Received September 12, 2011

    Report

    Report Number
    3004209178-2011-07697
    Event Type
    Injury
    Date Received
    September 12, 2011
    Report Date
    September 6, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PT HEARD AN ALARM, BUT WAS NOT CONFIRMED BY TELEMETRY. PT HAD RELOCATED AND WAS SEEING A NEW PHYSICIAN. THEY WERE THINKING THE PUMP WAS EMPTY. PT WAS TO GET A REFILL ON (B)(6) 2011 AND ALSO DO A DYE STUDY. IT WAS LATER REPORTED THAT THE PT'S PUMP WAS EMPTY AS THE PT HAD MISSED THE REFILL DATE AND DID NOT SEEK FURTHER ASSISTANCE WITH HER PUMP UNTIL AFTER RELOCATING IN A NEW STATE. THE PT INDICATED THAT SHE HAD EXPERIENCED INCREASED PAIN SYMPTOMS AND HAD BEEN EXPERIENCING THOSE SYMPTOMS SINCE HER PUMP HAD RUN DRY A COUPLE OF MONTHS PRIOR TO RELOCATION. THE PHYSICIAN OPTED TO REPLACE THE ENTIRE SYSTEM. THE NEW PUMP WAS FILLED WITH MORPHINE 5.0 MG/ML AND INITIALLY STARTED AT 0.2599/DAY TO START SINCE PT HAD BEEN WITHOUT DRUG FOR A COUPLE OF MONTHS. MORPHINE WAS ALSO THE DRUG INFUSED BY THE OLD PUMP. A DYE STUDY HAD BEEN CARRIED OUT PRIOR TO REPLACEMENT. THE PHYSICIAN ALSO FOUND THAT THE CATHETER COILED UNDERNEATH PUMP "INDICATING THAT THE PT MAY HAVE BEEN WITHOUT DRUG FOR LONGER THAN WHAT MAY HAVE BEEN EXPECTED BY SIMPLY A MISSED FILL AND SUBSEQUENT EMPTY PUMP". THE EVENT LOGS OF THE OLD PUMP INDICATED THAT A LOW RESERVOIR ALARM AND AN EMPTY RESERVOIR ALARM HAD OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT #N100896035