BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3232781 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-11937
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    June 23, 2013
    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 PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED AN INTRATHECAL BACLOFEN PUMP PATIENT HAD A ¿POTENTIAL WITHDRAWAL, OVERDOSE SCENARIO¿. IT WAS ALSO REPORTED, ¿NO MORE INFORMATION AT THIS POINT. MORE INFO TO COME¿. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REVEALED THE PUMP WAS USED TO DELIVER BACLOFEN, ¿AROUND¿ 500 MCG/DAY. IT WAS SAID THE SYMPTOMS INCLUDED ¿NOODLISH EXTREMITIES¿ AND PAIN. THE PATIENT WAS PLACED ON PAIN MEDICATION BECAUSE HIS SPASTICITY INCREASED FOLLOWED BY GETTING ¿EXTREMELY LOOSE¿ AFTER BEING PUT ON THE MEDICATION. THEY WERE UNSURE WHETHER THE PUMP WAS WORKING BECAUSE AS THEY TURNED DOWN THE PUMP, THERE WAS NO EFFECT AND THE INCREASED SPASTICITY CONTINUED. THE PUMP WAS THEN TURNED BACK UP. IT WAS STATED THE TYPE OF BACLOFEN USED WAS LIORESAL. IT WAS UNCLEAR AS TO WHETHER THE HEALTH CARE PROVIDER (HCP) ATTRIBUTED A REASON TO THE EVENT. THE HCP INDICATED ¿NONE¿ TO THE CAUSE OF THE EVENT, BUT ALSO INDICATED ¿UTI¿ AS THE ANSWER TO THE QUESTION, ¿IF THE EVENT WAS DUE TO THE PUMP, WHAT WAS THE ISSUE?¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332878 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00038 YR Other