BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2230756 · Received August 23, 2011

    Report

    Report Number
    3004209178-2011-06746
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 28, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0591-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HEARD A PUMP ALARM; THE CRITICAL ALARM WAS CONFIRMED BY TELEMETRY. THE REPORTER STATED THAT THE PATIENT PREVIOUSLY HAD AN MRI ON (B)(6) 2011 AND THAT IS WHEN THE EVENT STARTED. THE PUMP LOGS SHOWED MULTIPLE LOW BATTERY RESET LOGS AND THE PUMP WAS IN SAFE STATE. THE PUMP WAS ABLE TO BE REPROGRAMMED ON (B)(6) 2011. AT THE TIME OF THE REPORT, THE PATIENT HAD AN INFECTION SO SHE DID NOT HAVE SURGERY FOR THE PUMP. IT WAS NOT CLEAR AS TO WHETHER OR NOT THE INFECTION WAS RELATED TO THE PUMP. IT WAS UNDECIDED IF THE PUMP WAS GOING TO BE REPLACED. THE PUMP CONTAINED LIORESAL. THE PATIENT WAS PUT BACK ON ORAL BACLOFEN AND "SEEMS TO BE DOING OKAY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N150957003