BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 5255922 · Received November 30, 2015

    Report

    Report Number
    3004209178-2015-23505
    Event Type
    Malfunction
    Date Received
    November 30, 2015
    Report Date
    November 9, 2015
    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
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6 )2009, PRODUCT TYPE: CATHETER. PRODUCT ID: 85 90-1, LOT# N212396, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVING FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT RECEIVING INTRATHECAL GABLOFEN 2000 MCG/ML (DOSE 800 MCG/DAY). THE PUMP'S INDICATION FOR USE (IFU) WAS LISTED AS INTRACTABLE SPASTICITY AND MULTIPLE SCLEROSIS. A MOTOR STALL WAS SEEN AT INITIAL INTERROGATION AND THE PATIENT DID NOT RECENTLY HAVE A MAGNETIC RESONANCE IMAGING (MRI). WITHDRAWAL SYMPTOMS OCCURRED ON (B)(6) 2015; HOWEVER SPECIFIC SYMPTOMS WERE NOT MENTIONED. THE CHANGE IN THERAPY/SYMPTOMS WAS SUDDEN. THE PATIENT HEARD AN ALARM ON THE NIGHT OF (B)(6) 2015 AND PROCEEDED TO THE EMERGENCY ROOM (ER) AROUND MIDNIGHT. THE NURSE INTERROGATED THE PUMP AND CONFIRMED A MOTOR STALL. THE PATIENT WAS DISCHARGED FROM THE ER. THE REPORTER WAS ASKING ABOUT ORAL EQUIVALENTS TO INTRATHECAL BACLOFEN THERAPY (ITB); HOWEVER NO STANDARD ORAL EQUIVALENTS EXIST. ADDITIONALLY, INFORMATION WAS RECEIVED FROM A CONSUMER VIA COMPANY REPRESENTATIVE INDICATED THE PATIENT WAS RECEIVING INTRATHECAL LIORESAL 2000 MCG/ML (DOSE 991 MCG/DAY) VIA AN IMPLANTED PUMP. THEREFORE, THE SPECIFIC TYPE OF BACLOFEN USED IS DISCREPANT (INITIALLY REPORTED GABLOFEN). FOLLOW-UP IS UNDERWAY TO CLARIFY THIS INFORMATION. IT WAS FURTHER REPORTED, A MOTOR STALL WAS SEEN ON INITIAL INTERROGATION, BUT IT WAS UNKNOWN IF THE PATIENT HAD A RECENT MRI. ON (B)(6) 2015, THE PATIENT SEEMED CONFUSED AND DID NOT HAVE A "GOOD" DAY. ON (B)(6) 2015, THE PATIENT WAS HAVING A REFILL AND THERE WAS A MOTOR STALL NOTED (B)(6) 2015 AT 0155 AND THE PATIENT WAS HAVING WITHDRAWAL SYMPTOMS (INCREASED TONE). THE FAMILY AND PATIENT DID NOT HEAR AN ALARM. IN LOOKING AT THE LOGS, THE PATIENT HAD INTERMITTENT MOTOR STALLS AND RECOVERIES SINCE (B)(6) 2015. A MOTOR STALL (B)(6) 2015 AND MOTOR STALL RECOVERY ON (B)(6) 2015, MOTOR STALL (B)(6) 2015 AT 1438 AND RECOVERY (B)(6) 2015 AT 1513, MOTOR STALL (B)(6) 2015 AT 1620 AND MOTOR STALL RECOVERY (B)(6) 2015 AT 1625. THE LAST STALL WAS ON (B)(6) 2015 AT 0155 AND HAD NOT RECOVERED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784935 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR