BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 2212630 · Received August 11, 2011

    Report

    Report Number
    6000030-2011-06240
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    June 1, 2011
    Report Date
    July 15, 2011
    Manufacturer
    RICE CREEK MFG.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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

    FOLLOWING A PUMP AND CATHETER REPLACEMENT PROCEDURE, THE PT WAS HOSPITALIZED FOR A PERIOD OF "ABOUT A WEEK". IT WAS NOTED THAT A CATHETER ISSUE WAS FOUND DURING THE DEVICE REPLACEMENT PROCEDURE. THE PT STATED THE HOSPITAL/PAIN MGMT HEALTHCARE PROVIDER WOULD NOT REMOVE HIS STAPLES. THE STAPLES WERE "RED" AND SOME WERE STARTING TO LOOK "PUSY". THE PT BELIEVED HE WAS HOSPITALIZED DUE TO THE MEDICATION IN HIS PUMP, BUT NOTED HE WAS UNSURE OF THE EXACT REASON FOR THE HOSPITALIZATION. THE DRUG INFUSED WAS LIORESAL. THE PT'S CURRENT LOCATION WAS AT HOME; AND THE PT WAS PLANNING TO CONTACT AN HCP ABOUT REMOVING THE STAPLES. ADD'L INFO WILL BE PROVIDED IN A FOLLOW UP REPORT, AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MFG. 8627-18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Hospitalization| R CATHETER: MODEL 8709SC, OT# 279769005.| CATHETER: MODEL 8731, LOT# B005840N65.| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL 8637-40.| IMPLANTED:| IMPLANTED:| IMPLANTED:| LOT# NGV449443H| PROGRAMMER: MODEL 8835, LOT# NPG023696N.| IMPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 8835, LOT# NPG023696N| CATHETER: MODEL 8709SC, OT# 279769005| EXPLANTED:| LOT# NGV449443H| IMPLANTABLE INFUSION PUMP: MODEL 8637-40| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8731, LOT# B005840N65