BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1222418 · Received November 5, 2008

    Report

    Report Number
    3004209178-2008-07213
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    September 15, 2008
    Report Date
    October 9, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.,
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO THE MFR FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    FOLLOWING IMPLANT, THE PUMP WAS PROGRAMMED TO DELIVER BACLOFEN AT 235 MCG/DAY, WHICH WAS THE PT'S DOSE PRIOR TO THE NEW PUMP IMPLANT. THE PT EXPERIENCED A LACK OF THERAPEUTIC EFFECT. THE DOSE WAS INCREASED TO 300 MCG/DAY WITH MINIMAL TO NO EFFECT AND THE PT WAS GIVEN ORAL BACLOFEN WITH AN UNSATISFACTORY RESULT. A DYE STUDY WAS DONE VIA THE SIDE PORT (DATE NOT REPORTED) AND DID NOT INDICATED THAT ANYTHING WAS WRONG WITH ANY CONNECTING PARTS. A DECISION WAS MADE TO REPLACE THE PUMP. FOLLOWING THE REPLACEMENT, THE PUMP WAS FUNCTIONING PERFECTLY AND THE PT'S SPASTICITY WAS WELL CONTROLLED. THERE WAS NO PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATHETER: MODEL UNK