BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2100356 · Received May 13, 2011

    Report

    Report Number
    3004209178-2011-03501
    Event Type
    Malfunction
    Date Received
    May 13, 2011
    Date of Event
    April 19, 2011
    Report Date
    May 3, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE COMPONENTS HAVE BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING A NEW IMPLANT DONE. THE SPINAL SEGMENT OF THE CATHETER DID NOT THREAD PROPERLY WITH THE FIRST CATHETER ATTEMPT. THE CATHETER "BUCKLED" AND WOULD NOT PASS PROPERLY. THE PHYSICIAN FELT HEAVIER THAN NORMAL RESISTANCE. IT WAS NOTED THAT PIECES FROM EACH CATHETER KIT WERE USED OR IMPLANTED DURING THE CASE. THERE WAS NO PATIENT HARM. THE PATIENT WAS DOING WELL. THE PUMP WAS USED TO DELIVER LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR CATHETER: MODEL 8731SC, LOT# N284455007| EXPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8731SC, LOT# UNKNOWN| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8731SC, LOT# UNKNOWN| CATHETER: MODEL 8731SC, LOT# N275084010| IMPLANTED:| EXPLANTED:| IMPLANTED: