BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2992443 · Received March 7, 2013

    Report

    Report Number
    3004209178-2013-03430
    Event Type
    Injury
    Date Received
    March 7, 2013
    Report Date
    January 18, 2013
    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
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8709 LOT# J11024R12, IMPLANTED: 2002 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE PUMP REVEALED NO ANOMALY FOUND.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS RECEIVING POOR THERAPY EFFICACY AND TITRATIONS. BOTH DYE AND ROTOR STUDIES WERE PERFORMED AND WERE NORMAL. THE DEVICE WAS THOUGHT TO BE INVOLVED IN THE EVENT, SO THE SYSTEM WAS EXPLANTED. THERE WAS NO INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELA. THE DRUG USED IN THIS SYSTEM WAS LIORESAL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING AN INCREASE IN SPASTICITY. THE PATIENT WAS HAVING EFFECTIVE THERAPY POST REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98070 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00019 YR Required Intervention