BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5730179 · Received June 16, 2016

    Report

    Report Number
    3004209178-2016-12362
    Event Type
    Injury
    Date Received
    June 16, 2016
    Date of Event
    April 21, 2016
    Report Date
    August 1, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    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

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP). THE PATIENT'S OTHER MEDICATIONS INCLUDED GABAPENTIN, FOSAMAX, GILENYA, BENADRYL, OMEGA 3, MACRODANTIN, ZOLOFT, AMPYRA, CRESTOR, BACLOFEN, VESICARE, FLONASE, MULTIVIT. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIPLE SCLEROSIS (MS), DEPRESSION, CHRONIC FATIGUE, THYROID NODULE OBESITY, AND HYPERLIPIDEMIA. THE PATIENT HAD NO KNOWN ALLERGIES. THE CAUSE OF THE PAIN WAS MS EXACERBATION; THE PAIN WAS RELATED TO SPASTICITY.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER IN REGARDS TO A PATIENT WHO WAS BEING TREATED WITH BACLOFEN 1762.0 MG/ML AND FENTANYL 527.5 MG/ML INTRATHECAL THERAPY VIA AN IMPLANTED PUMP. THE DOSES AND THE LOT NUMBER WERE UNKNOWN. THE PUMP'S INDICATION FOR USE (IFU) WAS LISTED AS INTRACTABLE SPASTICITY. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE UNKNOWN. THE PATIENT WAS CURRENTLY IN THE HOSPITAL/HOSPITALIZED. HER LEGS WERE ¿A MESS¿ AND THEY ¿FELT WEIRD¿ THE DAY AFTER THE PUMP WAS IMPLANTED ((B)(6) 2016). SHE NOTICED THE DIFFERENCE THE DAY AFTER THE SURGERY. SHE THOUGHT IT WAS HER MULTIPLE SCLEROSIS SO SHE DID NOT MENTION THE ISSUE TO HER MANAGING PHYSICIAN. THE PATIENT STATED SHE COULD NOT FUNCTION AND IT WAS DIFFICULT FOR HER TO MOVE. MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED BUT THE MULTIPLE SCLEROSIS (MS) HADN¿T CHANGED IN TWO YEARS. SHE EXPERIENCED PAIN LAST SUNDAY, (B)(6) 2016. THERE WAS NO SENSATION IN HER LEGS AND WAS BED BOUND. THE SITUATION WAS BEING ADDRESSED BY THE HCP. ON (B)(6) 2016, THE MANUFACTURER REPRESENTATIVE WOULD BE MEETING WITH THE PATIENT WITH A PLAN TO INTERROGATE THE PATIENT¿S PUMP AND LOOK FOR ANY DIALOGUE BOX THAT MAY INDICATE AN ISSUE WITH THE PATIENT¿S PUMP AND REVIEW THE LOGS. THE REPRESENTATIVE WOULD REFER THE PATIENT TO THE MANAGING PHYSICIAN SHOULD THEY WANT TO PURSUE CATHETER DIAGNOSTICS. ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP) INDICATED OTHER MEDICATIONS THE PATIENT WAS TAKING AT THE TIME OF THE EVENT INCLUDED BENADRYL, FISH OIL, MACRODANTIN, ADDERALL, ZOLOFT, AMPYRA, CHESTOR, VESICARE, FLONASE, MULTI VITAMIN, FLOSAMAX, GILENYA. THE PATIENT¿S MEDICAL HISTORY INCLUDED MULTIPLE SCLEROSIS, DEPRESSION, INCREASED CHOLESTEROL, CHRONIC FATIGUE SYNDROME, THYROID NODULE AND THE PATIENT HAD NO KNOWN ALLERGIES. NO DIAGNOSTICS WERE PERFORMED AND NO ACTIONS OR INTERVENTIONS WERE TAKEN. THE CAUSE OF THE CHANGE IN THERAPY WAS NOT DETERMINED. THE CAUSE OF THE PAIN WAS ALSO NOT DETERMINED AND PAIN WAS NOT THE MAIN CONCERN. THE CHANGE IN THERAPY HAD NOT BEEN RESOLVED AND IT WAS BELIEVED TO BE A MULTIPLE SCLEROSIS EXACERBATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384133 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization