BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3092735 · Received May 3, 2013

    Report

    Report Number
    3004209178-2013-07297
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 10, 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
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, LOT# J11143R14, IMPLANTED: (B)(6) 2002. PRODUCT TYPE: CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF THE INFUSION PUMP REVEALED THE FOLLOWING: THERE WERE NO ANOMALIES FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING INCREASES IN PAIN THAT WERE BELIEVED TO BE WITHDRAWAL SYMPTOMS. THE PATIENT HAD ALSO PRESENTED WITH SWEATING AND FLU-LIKE SYMPTOMS INCLUDING BODY PAIN. THE PUMP LOGS APPEARED TO BE NORMAL AND AN "INTEROPERATIVE" DYE STUDY WAS ATTEMPTED, BUT WAS ABORTED BECAUSE THE CATHETER COULDN'T BE ASPIRATED. THE PHYSICIAN DECIDED TO PERFORM EXPLORATORY SURGERY AND ENDED UP REPLACING THE PUMP AND PUMP CONNECTOR. THE DEVICE SYSTEM WAS DELIVERING CLONIDINE AND BUPIVACAINE. TWENTY DAYS LATER, IT WAS REPORTED THAT THE PATIENT HAD PRESENTED TO THE EMERGENCY ROOM WITH INCREASED PAIN. THE PATIENT HAD A RETURN OF PAIN AND UNDERLYING SYMPTOMS. THE DYE STUDY CAME BACK NEGATIVE FOR ANY CATHETER ISSUES. THERE WAS NO PATIENT INJURY AND HE RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT PRIOR TO REPLACING THE PUMP, THE PUMP WAS "PERFECT" AND WORKING FINE FOR HIM, UNTIL HE "WENT INTO WITHDRAWALS ONE WEEKEND. THE INABILITY TO ASPIRATE FLUID WAS RELAYED AS AN ISSUE "SOMEWHERE BETWEEN THE PUMP PROBABLY AT THE CONNECTION". THE PATIENT FURTHER STATED "IT WAS DISCONNECTED OR IT DIDN'T WORK". THE FLU-LIKE SYMPTOMS PREVIOUS REPORTED OCCURRED FOR ABOUT 4 OR 5 WEEKS PRIOR TO HAVING THE PUMP REPLACED, AS THE PATIENT BELIEVED HE WAS GETTING "LESS MEDICINE" DURING THAT TIME. THE SYMPTOMS INCLUDED STOMACH ACHES, AND NAUSEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194666 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention