BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2143007 · Received June 23, 2011

    Report

    Report Number
    3004209178-2011-04731
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 1, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, IT WAS INITIALLY REPORTED THAT THE PT HAD RECENTLY NOTICED SLIGHT SWELLING/TENDERNESS AT THE CATHETER INCISION, ON THE PT'S BACK. INCREASED SPASTICITY WAS ALSO NOTED TO HAVE OCCURRED AT NIGHT. NO ACTIVITY OR OBVIOUS CHANGES WERE NOTED, WHICH WOULD HAVE RESULTED IN THE NEW SYMPTOMS. THE MEDICATION ADMINISTERED VIA THE PUMP WAS BACLOFEN. ON (B)(6) 2011, IT WAS FURTHER REPORTED THAT THE PT WAS SCHEDULED FOR A CATHETER REPLACEMENT/REVISION PROCEDURE TODAY. X-RAYS WERE INDICATED TO HAVE "LOOKED OK". ON (B)(6) 2011, IT WAS REPORTED THAT NO PRODUCT WAS TO BE RETURNED TO THE MFR. THE PT'S OUTCOME REGARDING THE REVISION/REPLACEMENT PROCEDURE WAS INDICATED AS UNK. ADD'L INFO 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
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention EXPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# J0058118R| IMPLANTED:| IMPLANTED:| CATHETER: MODEL 8575, LOT# N193638