BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3112407 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-07654
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 26, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER A PUMP REPLACEMENT PREVIOUSLY REPORTED IN MANUFACTURER REPORT #3004209178-2013-03155, THE PATIENT WOKE UP FROM SURGERY AND WAS BACK TO A FUNCTIONAL LEVEL FOR AT LEAST 5 HOURS. THE PATIENT'S DOSE POST-SURGERY WAS 100 MCG/D. WITHIN 15 MINUTES, IT WAS REPORTED THAT THE PATIENT WENT FROM TALKING TO SEVERE SEIZURES. THE PATIENT DID NOT HAVE ANY INCREASE IN SPASMS, TONE, OR REPORTS OF ITCHING. THE NEUROSURGERY TEAM REPORTED THE PATIENT HAD ACUTE RESPIRATORY DISTRESS SYNDROME AND THE PATIENT HAD A TRACH PLACED. THE TEAM EVALUATED THE PATIENT'S SYMPTOM PRESENTATION AS A POSSIBLE WITHDRAWAL, BUT IT WAS RULED OUT. THE PATIENT WAS ALMOST TO A THERAPEUTIC DOSE NOW AT APPROXIMATELY 300 MCG/D. DRUG IN PUMP IS LIORESAL 500MCG/ML. THIS EVENT HAD BEEN PREVIOUSLY REPORTED UNDER MANUFACTURER REPORT # 3004209178-2013-03155. ANY ADDITIONAL INFORMATION REGARDING THIS POST-PUMP REPLACEMENT EVENT WILL BE REPORTED IN THIS MANUFACTURER REPORT NUMBER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE DRUG WAS LIKELY GABLOFEN BECAUSE THE REFILL WAS DONE OUTSIDE OF THE IMPLANTING INSTITUTION. THE HEALTH CARE PROVIDER (HCP) FROM THE ADMITTING FACILITY REPORTEDLY BELIEVED THE SEIZURES CAUSED THE RESPIRATORY DISTRESS. A CATHETER ACCESS PORT PROCEDURE WAS DONE AND THE ADMITTING FACILITY VERIFIED THE VOLUMES IN THE RESERVOIR MATCHED THE PROGRAMMER AMOUNTS. THE PATIENT HAS REPORTEDLY RECOVERED WITHOUT ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S PUMP WAS USED TO INFUSE LIORESAL. IT WAS NOTED THAT THE PATIENT¿S BACLOFEN INTRATHECAL TREATMENT WAS ON-GOING. IT WAS REPORTED THAT THERE WERE NO OTHER MEDICATION CONTAINED IN THE PUMP AT THE TIME OF THE EVENT. IT WAS NOTED THAT THE PATIENT¿S SEIZURES POST-OPERATIVELY WERE SUSPECTED TO BE RELATED TO SEVERE METABOLIC DERANGEMENT, OVERWHELMING INFECTION, UNDERLYING SEIZURE DISORDER AND PSYCHIATRIC CONDITION. IT WAS REPORTED NOT TO BE RELATED TO INTRATHECAL BACLOFEN (ITB) DOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211860 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00026 YR Life Threatening| R