BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3932578 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-12975
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    T WAS NOW PROVIDED THAT THE PHYSICIAN INDICATED THE PATIENT WAS FEELING ¿VERY GOOD,¿ HIS SPASTICITY WENT DOWN, AND THE PATIENT WAS TO RETURN FOR THE FIRST REFILL IN SEPTEMBER. AT THAT TIME AN X-RAY WILL BE PERFORMED. IF THE PUMP CANNOT BE FLIPPED THE PATIENT WILL BE CONSIDERED FOR A SURGICAL REVISION TO FLIP THE PUMP. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    FURTHER, THE PATIENT DID NOT/DOES NOT HAVE SYMPTOMS AND THE CAUSE OF THE EVENT WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED TO DETERMINE THE RESOLUTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED ,A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS LATER PROVIDED THAT THE PUMP HAD FLIPPED. THE PHYSICIAN PERFORMED THE REFILL WITH X-RAY, WHICH WENT WELL, AND ALSO FLIPPED IT SUCCESSFULLY. THE PHYSICIANS DID NOT WANT TO OPERATE ON THIS PATIENT SINCE HE HAS HAD A HISTORY OF INFECTIONS AND "LOTS OF OTHER PROBLEMS." CLARIFICATION WAS REQUESTED TO DETERMINE IF THE PATIENT'S INFECTIONS AND OTHER PROBLEMS WERE RELATED TO THE IMPLANTED DEVICE SYSTEM AND/OR THERAPY. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THE REPORT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS FURTHER CLARIFIED THAT THE PATIENT¿S PREVIOUS INFECTIONS AND ¿LOTS OF OTHER PROBLEMS¿ DID NOT INVOLVE NOR WERE CONNECTED TO THE PUMP. THE PATIENT FEELS GREAT WITH THE PUMP, HAS LESS SPASTICITY, AND WAS VERY HAPPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIANS SUSPECTED THAT THE PUMP FLIPPED IN THIS PATIENT. X-RAYS WERE TAKEN. REPORTEDLY, THERE WAS NO PATIENT HARM AND NO ACTION TAKEN AT THE TIME OF THE REPORT. THIS DEVICE SYSTEM DELIVERED BACLOFEN. 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
    409230 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1