BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1936130 · Received December 13, 2010

    Report

    Report Number
    3004209178-2010-10381
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 22, 2010
    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
    NY, 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

    THE PT EXPERIENCED LACK OF PAIN RELIEF. THE ASPIRATED RESERVOIR VOLUME DID NOT MATCH THE EXPECTED VOLUME DURING A PUMP REFILL. THE CATHETER COULD NOT BE ASPIRATED DURING A DYE STUDY. DURING SURGERY, THE CATHETER WAS FOUND TO BE PATENT. THE PHYSICIAN BELIEVED THE PUMP WAS NOT WORKING. THE PUMP CONTAINED DILAUDID. THE PUMP WAS REPLACED. THE PT RECOVERED WITHOUT SEQUELA.

    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 48 YR Required Intervention IMPLANTED:| CATHETER: MODEL 8709SC, LOT # N255658008| IMPLANTED:| ACCESSORY: MODEL 8590-1, LOT# N209640| EXPLANTED:| EXPLANTED: