BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2210315 · Received August 9, 2011

    Report

    Report Number
    3004209178-2011-06176
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    June 1, 2011
    Report Date
    July 18, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PERSISTENT WITHDRAWAL SYMPTOMS FOR THREE WEEKS. A ROTOR AND DYE STUDY WERE PERFORMED WHICH WERE NEGATIVE. THE DEVICE WAS REPLACED, THE REASON STATED WAS "THERAPY-RELATED." PATIENT OUTCOME WAS REPORTED AS RECOVERED WITHOUT SEQUELAE. THE DRUG INFUSED VIA THE PUMP WAS DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8578, LOT # N192197009| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT # J11579R03