BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4190081 · Received October 21, 2014

    Report

    Report Number
    3004209178-2014-20099
    Event Type
    Injury
    Date Received
    October 21, 2014
    Report Date
    October 14, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND NO ANOMALY.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    FOLLOWING A CATHETER REPLACEMENT ON (B)(6) 2014 (PLEASE REFER TO MANUFACTURER¿S REPORT #3004209178-2014-09852), THE PATIENT RECOVERED WITHOUT SEQUELA. AFTER SEVERAL DAYS THEY EXHIBITED SIGNS OF INCREASED TONE. THERE WAS NO OTHER CAUSE FOR THE INCREASED TONE, SO IT WAS SUSPECTED THAT IT MAY BE RELATED TO A PUMP MALFUNCTION. THE PUMP WAS REPLACED ON (B)(6) 2014 DUE TO A SUSPECTED PUMP MALFUNCTION. A NEW PUMP WAS PLACED, BUT THE PATIENT STILL HAD INCREASED TONE. A DYE STUDY WAS PERFORMED ON (B)(6) 2014 WHICH REVEALED AN OCCLUDED CATHETER. THE DECISION WAS MADE TO FOREGO A REVISION OF THE CATHETER AND ABANDON THE THERAPY. AN INTRATHECAL BACLOFEN WEAN WAS INITIATED AT THAT TIME. THERE WERE NO PLANS TO EXPLANT THE PUMP THAT WAS IMPLANTED ON (B)(6) 2014. THE PATIENT REPORTEDLY RECOVERED WITHOUT SEQUELA. THE PUMP CONTAINED GABLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668738 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention