BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3824597 · Received May 21, 2014

    Report

    Report Number
    3004209178-2014-09376
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 30, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD AN OVERDOSE FROM (B)(6) 2014. THE PATIENT HAD BEEN HOSPITALIZED AT THAT TIME.

    Description of Event or Problem · 1

    FOLLOWING A ROUTINE REFILL ON (B)(6) 2014, THE PATIENT REPORTED FEELING ¿FUNNY¿. THE HEALTHCARE PROFESSIONAL (HCP) THOUGHT THE PATIENT HAD AN OVERDOSE. THE PATIENT WAS GIVEN TWO DOSES OF NARCAN (0.4MG). DURING THIS TIME, THE PATIENT WAS CONSCIOUS, AWAKE AND BREATHING. SINCE ¿BEING SHOT UP WITH NARCAN; THE PATIENT HAS HAD CHANGES IN HIS BODY. A CT (COMPUTERIZED TOMOGRAPHY) WAS PERFORMED ON (B)(6) 2014 AND THE CATHETER WAS OK, THE PUMP WAS WORKING AND THERE WAS NO LEAKAGE. THE PATIENT ALSO TAKES ORAL PERCOCET TWICE DAILY FOR BREAKTHROUGH PAIN. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE AND MARCAINE. ADDITIONAL INFORMATION LATER INDICATED THAT THE PATIENT COMPLAINED OF BACK NUMBNESS AT THE L5-S1 AREA. A CT SCAN WAS PERFORMED ON (B)(6) 2014 AND WAS NEGATIVE. THERE WAS NO EVIDENCE OF ACUTE INTRA-ABDOMINAL OR INTRA-PELVIC DISEASE. THE INFUSION PUMP HAD NO EVIDENCE OF ANY DISEASE, SURROUNDING FLUID COLLECTION OR INFLAMMATION. THERE WAS NO COLLECTION IDENTIFIED AROUND THE CATHETER AND THERE WERE NO OBVIOUS INFLAMMATORY CHANGES. THE PATIENT WAS SCHEDULED FOR AN OFFICE VISIT ON (B)(6) 2014 FOR FOLLOW-UP; HOWEVER, HE REFUSED TO BE SEEN WITHOUT HIS MOTHER AND LEFT WITHOUT SEEING THE PHYSICIAN. THE HEALTHCARE PROFESSIONAL INDICATED THAT THE PATIENT HAD A POSSIBLE ALLERGY TO NARCAN. IT WAS NOTED THAT THE PATIENT WAS TAKING OXYCODONE ORALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302448 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR Required Intervention