BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2052522 · Received April 11, 2011

    Report

    Report Number
    3004209178-2011-02727
    Event Type
    Injury
    Date Received
    April 11, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 2, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MFR EMPLOYEE. A PROCESS IMPROVEMENT PLAN AND TRAINING ARE IN PLACE. THE PUMP AND CATHETER HAS BEEN RETURNED TO THE MFR FOR ANALYSIS. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT EXPERIENCED WITHDRAWAL. SPECIFIC SYMPTOMS ASSOCIATED WITH THE EVENT WERE NOT REPORTED. THE CATHETER ACCESS PORT COULD NOT BE ASPIRATED. THE PUMP AND CATHETER WERE EXPLANTED AND REPLACED. NEITHER A ROTOR NOR A DYE STUDY WAS PERFORMED. PER THE REPORTER, THERE WAS NO PT INJURY. THE MEDICATION BEING ADMINISTRATED VIA THE PUMP WAS LIORESAL. ADDITIONAL 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 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention IMPLANTED:| CATHETER: MODEL 8709, LOT# J11535R27| CATHETER: MODEL 8578, LOT# N167123018| EXPLANTED:| EXPLANTED:| IMPLANTED: