BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2162059 · Received July 12, 2011

    Report

    Report Number
    3004209178-2011-05360
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 20, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S DEVICE WAS REMOVED ON (B)(6) 2011. THE PT WAS RECEIVING INADEQUATE PAIN RELIEF. THERE WAS NO PT INJURY. THE PT RECOVERED WITHOUT SEQUELAE. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS DILAUDID. ADDITIONAL INFO HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention CATHETER: MODEL CATHETER, LOT# UNKNOWN| EXPLANTED:| IMPLANTED:| IMPLANTED:| CATHETER: MODEL 8731SC, LOT# N114045028| EXPLANTED: