BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2120025 · Received June 8, 2011

    Report

    Report Number
    3004209178-2011-04154
    Event Type
    Injury
    Date Received
    June 8, 2011
    Date of Event
    January 1, 2011
    Report Date
    May 11, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT'S CATHETER HAD FALLEN OUT OF INTRATHECAL SPACE, AND WAS COILED AT BASE OF SPINE. THIS RESULTED IN LARGE LUMP. THE PUMP WAS NOTED AS PROTRUDING, DUE TO PT WEIGHT LOSS. THE PUMP WAS ALSO THOUGHT TO BE TOO LARGE, AND THERE WAS CONCERN FOR SKIN BREAKDOWN. THE PT'S SYSTEM WAS INDICATED AS BEING NON-FUNCTIONAL. THE PUMP AND CATHETER WERE EXPLANTED AND REPLACED. A SMALLER PUMP WAS IMPLANTED. THE PT WAS NOT INJURED, AND HAD RECOVERED FROM THE PROCEDURE WITHOUT SEQUELA. DILAUDID AND BUPIVACAINE (DAILY DOSE: 0.180 MG/DAY, CONCENTRATION: 30 MG/ML) WERE ADMINISTERED VIA THE PUMP. 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 48 YR Required Intervention EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N197622007| IMPLANTED: