BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2212648 · Received August 11, 2011

    Report

    Report Number
    3004209178-2011-06262
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 20, 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
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPOT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS NOT HAVING A SPASTICITY REDUCTION DESPITE INCREASED "INTRATHECAL DOSES, BOLUS TEST, ETC". A DYE STUDY WAS ATTEMPTED; HOWEVER, THE CATHETER WAS NOT ABLE TO BE CLEARED. THE PT WAS TAKEN TO THE OPERATING ROOM ON (B)(6) 2011. THE PT'S PUMP AND PUMP CONNECTOR WERE REPLACED; AND THE CATHETER WAS EXPLORED. THE DOSE WAS LOWERED, AND THE PT WAS NOTED AS "DOING OK TODAY". A FOLLOW-UP VISIT WAS SCHEDULED FOR (B)(6) 2011. THE DRUG DELIVERED WAS LIORESAL, 450 MCG/DAY. FOLLOWING THE PT'S PHYSICIAN VISIT, THE PT WAS NOTED AS DOING FINE. NO CATHETER ISSUES WERE FOUND. IT WAS LATER REPORTED THAT THE PT WAS NEVER HAVING THERAPEUTIC EFFECT; TWO WEEKS POST-OPERATION. A VOLUME DISCREPANCY WAS NOTED, IN WHICH THE ACTUAL RESIDUAL VOLUME WAS FOUND TO BE GREATER THAN THE EXPECTED RESIDUAL VOLUME. SPECIFIC VOLUMES WERE NOT REPORTED. PUMP LOGS WERE CHECKED, AND THE PUMP APPEARED TO BE FUNCTIONING PROPERLY. LIORESAL DOSE RATE: "CURRENT" AS BEING 480, AND "NEW" AS BEING "MINIMUM RATE MODE". ADD'L INFO WILL BE PROVIDED IN A FOLLOW UP REPORT, AS IT BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N291938005