BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2120196 · Received June 6, 2011

    Report

    Report Number
    3007566237-2011-04045
    Event Type
    Injury
    Date Received
    June 6, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 7, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PT EXPERIENCED A RETURN OF SPASTICITY AFTER TREATMENT IN A SWIMMING POOL. THE PT WAS GIVEN A BOLUS OF 150 MCG WITH NO EFFECT. THE CATHETER WAS CHECKED. ASPIRATION WAS POSSIBLE (APPROX. 0.2 ML OF CSF). THEY THEN INJECTED CONTRAST MEDIUM (10 CC); NO OPACIFICATION WAS SEEN. RE-ASPIRATION OF THE 10 CC WAS POSSIBLE. THEY THEN DID A NEW PUNCTURE VIA THE ACCESS PORT AND INJECTED 10 CC OF CONTRAST MEDIUM. THE CONTRAST MEDIUM WAS SEEN NEAR THE PUMP. THE DECISION WAS MADE TO CHANGE THE ENTIRE SYSTEM; THE PUMP ERI (ELECTIVE REPLACEMENT INDICATOR) WAS 6 MONTHS. THE PUMP AND CATHETER WERE REPLACED. IT WAS NOTED THAT WHEN THE CATHETER WAS CUT GOOD CSF BACKFLOW COULD BE SEEN (NEVERTHELESS THE ENTIRE CATHETER WAS CHANGED). ONCE THE PUMP WAS EXPLANTED, INJECTION WAS POSSIBLE IN THE ACCESS PORT AND DROPLETS OF MEDICATION COULD BE SEEN AFTER A BOLUS. THERE WAS REPORTED TO BE NO PT INJURY. IT WAS FURTHER REPORTED THAT DURING THE REVISION, THE CONNECTION BETWEEN THE PUMP AND CATHETER WAS CHECKED VIA INJECTION INTO THE SIDE PORT; THEY HAD NO PROBLEM DURING THE INJECTION, NO DAMAGE WAS OBSERVED AND THERE WAS NO LEAKAGE SEEN. FOLLOWING THE PUMP AND CATHETER REPLACEMENT, THE PT WAS STABLE AND HAD RETURNED TO A "STEADY STATE." THE DRUG IN THE PUMP AT THE TIME OF THE EVENT WAS LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention IMPLANTED:| CATHETER: MODEL CATHETER, LOT# UNKNOWN| EXPLANTED: