BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4101933 · Received September 19, 2014

    Report

    Report Number
    3004209178-2014-17369
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER; PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, WHEN THE PATIENT LEANED FORWARD, HE EXPERIENCED PAIN. THE PAIN DID NOT COME ON RIGHT AWAY, BUT WOULD BUILD UP OVER SEVERAL SECONDS. WHEN THE PATIENT STRAIGHTENED UP, IT WOULD RESOLVE, BUT NOT IMMEDIATELY. THE PATIENT DESCRIBED A DELAYED REACTION RELATED TO THIS PAIN. IT WAS NOTED THAT THIS PAIN MAY HAVE STARTED A FEW DAYS TO A WEEK AFTER THE PATIENT GOT HOME FROM THE HOSPITAL. WHEN ASKED IF THE PATIENT EXPERIENCED ANY MORE SYMPTOMS, IT WAS STATED THAT THE THERAPY WORKED WELL FOR THE PATIENT¿S MUSCLE SPASMS, BUT THE HEALTHCARE PROVIDER (HCP) WANTED TO CHECK CATHETER PLACEMENT VIA TO SEE IF IT MAY HAVE BEEN A CONTRIBUTOR TO THE PATIENT¿S SYMPTOMS WHEN LEANING FORWARD. ON THE DAY OF THIS REPORT, THE PATIENT HAD AN MRI BECAUSE THE HCP THOUGHT THAT THE CATHETER MAY HAVE MIGRATED. THE MRI BEGAN AT 12:30PM AND WAS COMPLETED AT 1:40PM. AT APPROXIMATELY 3:30PM, THE PATIENT BEGAN HEARING AN ALARM. THE ALARM SOUNDED LIKE A FOREIGN AMBULANCE. AT THE TIME OF THIS REPORT, THE PATIENT WAS WAITING TO BE SEEN IN THE EMERGENCY ROOM (ER), BUT WAS TOLD TO CALL THE MANUFACTURER REPRESENTATIVE. THE PATIENT HAD BEEN UNABLE TO REACH HIS MANAGING HCP. IT WAS NOTED THAT THE PATIENT HAD ORAL BACLOFEN AVAILABLE AT HIS HOME. IT WAS ALSO NOTED THAT THE PATIENT HAD NOT HAD A REFILL SINCE HIS PUMP IMPLANT. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. THE PATIENT¿S MEDICAL STATUS PRIOR TO THIS REPORT, RESULTS OF THE MRI, CAUSE OF THE ALARM, CAUSE OF THE EVENT, TROUBLESHOOTING/DIAGNOSTICS, INTERVENTIONS/TREATMENTS, AND FINAL PATIENT OUTCOME WERE NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582704 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1