BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2223860 · Received August 18, 2011

    Report

    Report Number
    3004209178-2011-06565
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 27, 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 Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN ASPIRATED 20 ML OF DRUG FROM THE PUMP RESERVOIR DURING REFILL PROCEDURE. HE TRIED TO PERFORM A CAP TEST TO ASSESS THE CONDITION OF THE CATHETER BUT NO FLUID COULD BE ASPIRATED OR FILLED IN THE CATHETER THROUGH THE CAP DUE TO "VERY HIGH RESISTANCE". A CATHETER CONNECTION ISSUE WAS SUSPECTED. THE PT UNDERWENT "SURGERY TO RESTORE PROPER PUMP TO CATHETER CONNECTION." THE PHYSICIAN OPENED THE PUMP POCKET IN SURGERY, CHECKED BOTH THE PUMP AND CATHETER WHILE DISCONNECTED (FROM CAP TO THE PUMP CATHETER PORT), RECONNECTED THEM, AND THE FLOW WAS RESTORED. NO PT SYMPTOMS OR OUTCOME WERE REPORTED. THE PUMP CONTAINED BACLOFEN. 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 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8731SC, LOT# 0204336318