BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2102377 · Received May 20, 2011

    Report

    Report Number
    3004209178-2011-03697
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 22, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A CATHETER PROBLEM. THE SUTURELESS CONNECTOR WAS NOT CONNECTED PROPERLY TO THE PUMP. A REVISION HAD BEEN SCHEDULED FOR (B)(6) 2011. THE PT DRANK COFFEE PRIOR TO SURGERY, SO THE SURGERY WAS CANCELLED, AND HAD NOT BEEN RESCHEDULED AS OF THE DATE OF THIS REPORT. THE DRUG IN THE PUMP AT THE TIME OF THE EVENT WAS BACLOFEN. ADD'L INFO HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    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 40 YR CATHETER: MODEL 8709SC, LOT# N270988010| IMPLANTED:| EXPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N244710001| IMPLANTED:| ACCESSORY: MODEL 8590-1, LOT# N266142| EXPLANTED:| IMPLANTED: