BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3092589 · Received May 3, 2013

    Report

    Report Number
    3004209178-2013-07284
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    May 2, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-3043-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709, LOT# J10847R26, IMPLANTED: (B)(6) 2001, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE PUMP NGP302018H REVEALED A HIGH RESISTANCE PUMP BATTERY.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT BEGAN HAVING WITHDRAWAL SYMPTOMS THE DAY PRIOR TO THE REPORT AND THE SYMPTOMS HAD GOTTEN PROGRESSIVELY WORSE. THE REPORTER INDICATED THAT THE EVENT LOGS READ "RESET OCCURRED", "LOW BATTERY RESET OCCURRED", AND "PUMP IS IN SAFE STATE" ON (B)(6) 2013. NO PUMP ALARM WAS HEARD. TROUBLESHOOTING WAS PERFORMED IN AN ATTEMPT TO PROGRAM THE PUMP OUT OF THE RESET. THE DEVICE SYSTEM WAS USED TO DELIVER GABLOFEN (BACLOFEN). IT WAS LATER REPORTED THAT THE PATIENT'S PUMP WAS "FAIRLY CLOSE TO THE END OF HER BATTERY LIFE" BUT THE WEEK PRIOR TO THE REPORT "FOR SOME REASON THE PUMP STOPPED, DID NOT ALARM." NO ONE HAD HEARD THE PUMP ALARMING; HOWEVER, A CRITICAL ALARM DUE TO SAFE STATE WAS CONFIRMED BY TELEMETRY. THE REPORTER STATED THAT THE PUMP WAS PROGRAMMED TO ALARM EVERY 10 MINUTES FOR A CRITICAL ALARM. THE PATIENT WAS CURRENTLY IN THE OPERATING ROOM (OR) TO HAVE THE PUMP REPLACED. IT WAS LATER CONFIRMED THAT THE PUMP WAS REPLACED ON (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUDIBLE ALARM WAS HEARD DURING THE SURGERY. IT WAS LATER REPORTED THAT THE PATIENT WAS MORE SPASTIC PRIOR TO ARRIVING AT THE HOSPITAL. THE CAUSE OF THE ALARM DUE TO SAFE STATE WAS UNKNOWN. FOLLOWING THE PUMP REPLACEMENT SURGERY THE PATIENT WAS REPORTED TO HAVE BEEN DOING WELL AND THERE WERE NO KNOWN COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194069 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention