BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1844558 · Received September 23, 2010

    Report

    Report Number
    3004209178-2010-07246
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 26, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT OVER TIME, FOLLOWING SEVERAL REFILLS, A PUMP'S EFFICIENCY HAD REDUCED. IT WAS INITIALLY NOTED THAT ON ONE OCCASION, THE PUMP COULD NOT BE REFILLED. THE PT WAS ADMITTED TO A HOSPITAL ON (B)(6)2010. THE PUMP WAS EXPLANTED AND REPLACED THE FOLLOWING DAY, AS THE PHYSICIAN PERFORMING THE SURGERY WAS UNDER THE IMPRESSION THAT THE PUMP WAS UNABLE TO BE REFILLED. CATHETER PATENCY WAS CONFIRMED PRIOR TO THE REPLACEMENT SURGERY. AN MRI WAS CONDUCTED IN SEPTEMBER, AND NO INFLAMMATORY MASS WAS FOUND. UPON OPENING THE PUMP POCKET, THE DEVICE WAS FOUND TO BE IN THE CORRECT POSITION. AFTER THE PUMP WAS REPLACED, THE PHYSICIAN ASPIRATED 41 MLS OF THE OLD DRUG FROM THE ORIGINAL PUMP, AS IT HAD BEEN ACTUALLY FILLED THE DAY BEFORE BY ANOTHER PHYSICIAN WITH NOTED DIFFICULTY. IN REGARDS TO THE DIFFICULTY WITH REFILLING THE ORIGINAL PUMP, THE PHYSICIAN HAD MOMENTARILY STOPPED THE REFILLING PROCESS AFTER EXPERIENCING RESISTANCE, BUT EVENTUALLY WAS ABLE TO REFILL THE PUMP. IT WAS NOTED THAT THE PUMP WAS REPLACED IN ERROR, AS THE PHYSICIAN PERFORMING THE REPLACEMENT PROCEDURE WAS UNDER THE IMPRESSION THAT THE PUMP REFILL THE DAY BEFORE WAS NOT ABLE TO BE COMPLETED. THE PHYSICIAN CONFIRMED THAT IN THE END THERE WAS NO MALFUNCTION IN REGARDS TO THE INITIAL PUMP, AND HENCE THE REPLACEMENT SURGERY WAS NOT NECESSARY. A PUMP ROLLER STUDY WAS NOT CONDUCTED. THE EXPLANTED PUMP WAS RETURNED TO THE MANUFACTURER TO CONFIRM IF THE PUMP HAD ANY ISSUES. THE FOLLOWING MEDICATIONS WERE ADMINISTERED VIA THE PUMP: HYDROMORPHONE (1,250 MCG/ML @ 641.8 MCG/DAY), CLONIDINE (100.0 MCG/ML @ 51.35 MCG/DAY), AND BUPIVACAINE (5000.0 MCG/ML @ 2,567.3 MCG/DAY). THE PT'S OUTCOME WAS NOT REPORTED, HOWEVER, IT WAS NOTED THAT THERE WAS NO INCIDENCE OF PT INJURY. ADDITIONAL INFO 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
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention