BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5077670 · Received September 15, 2015

    Report

    Report Number
    3004209178-2015-17958
    Event Type
    Injury
    Date Received
    September 15, 2015
    Report Date
    August 20, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: CATHETER. PRODUCT ID: 8840, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CONSUMER THAT ON (B)(6) 2015 PATIENT HAD A LITTLE PAIN, ON (B)(6) 2015 THE PATIENT HAD A LOT OF PAIN AND WAS SLURRING. IT WAS NOTED THAT THE PATIENT WAS LAYING IN THE FETAL POSITION AND SAYING THEY WANTED TO DIE. ON (B)(6) 2015 THE PATIENT HAD PAIN, SLURRING, AND HAD DISTRESS SO THEY TOOK THE PATIENT TO THE EMERGENCY ROOM (ER). IN THE ER THE PUMP WAS FOUND TO BE EMPTY, AND THE ALARM HAD NOT GONE OFF. THEY SPOKE TO THE PAIN DOCTOR AND THE HEALTHCARE PROFESSIONAL (HCP) SAID THE PUMP SHOULD NOT BE EMPTY BECAUSE THE REFILL DATE WAS (B)(6) 2015. THE HCP LATER DETERMINED THAT THE PATIENT'S REFILL DATE SHOULD HAVE BEEN (B)(6) 2015. NEITHER THE LOW OR EMPTY RESERVOIR ALARMS HAD OCCURRED, THE PATIENT'S PROGRAMMING SHOWED THAT THE LOW RESERVOIR ALARM DATE WAS SET AT (B)(6) 2015. IN THE EMERGENCY ROOM THEY ATTEMPTED TO GIVE THE PATIENT AN UNKNOWN INTRAVENOUS PAIN MEDICATION. THE PATIENT WAS IN THE HOSPITAL WITH TERRIBLE PAIN, THE PATIENT'S BLOOD PRESSURE WAS 210 - 215 AND THE PATIENT HAD A MINOR STROKE. IT WAS NOTED THAT THE PUMP WAS WORKING BEAUTIFULLY AND IT IS NOW WORKING AGAIN SINCE THE EMPTY RESERVOIR HAD BEEN REFILLED, THE PATIENT DID NOT HAVE ANY PAIN AFTER IT WAS REFILLED. IT WAS ALSO NOTED THAT THE PATIENT'S PAIN AND QUALITY OF LIFE HAVE IMPROVED SINCE THEY HAVE GOTTEN THE PUMP. HOWEVER, NOW THE PATIENT NEEDS 24 HOUR CARE AFTER THEIR STROKE. IT WAS NOTED THAT THE STROKE PART IS IRREVERSIBLE. AT THE TIME OF THE EVENT THE PUMP WAS USED TO INFUSE FENTANYL (0.5 MCG/ML; 0.30039 MCG/DAY) AND MORPHINE (0.5 MG/ML; 0.30039 MG/DAY). THE INDICATION FOR USE IS NON-MALIGNANT PAIN. FURTHER FOLLOW UP IS BEING CONDUCTED TO DETERMINE, IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    2015-10-07, ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP). THE CAUSE OF THE INCORRECT LOW RESERVOIR ALARM DATE WAS THAT THE PATIENT WAS GIVEN THE WRONG REFILL DATE. THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PATIENT WAS HARD OF HEARING AND COULD NOT HEAR THE ALARMS. THE PATIENT WAS TAKING OTHER MEDICATIONS AT THE TIME OF THE EVENT BUT IT WAS NOT INDICATED WHAT THEY WERE. MEDICAL HISTORY WAS CHRONIC BACK PAIN. THE INTRATHECAL DRUG THERAPY WAS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608332 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR Hospitalization| S