BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2093943 · Received May 16, 2011

    Report

    Report Number
    3004209178-2011-03542
    Event Type
    Injury
    Date Received
    May 16, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 14, 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
    FL, 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

    A PATIENT EXPERIENCED WITHDRAWAL SYMPTOMS ON TWO SEPARATE OCCASIONS, WITH ONE OCCASION OCCURRING IN (B)(6) 2011, AND THE OTHER IN (B)(6) 2011. THE PATIENT HAD HEARD A PUMP ALARM WHEN THE PUMP WAS FULL/RECENTLY FILLED. BOTH A ROTOR AND DYE STUDY WERE PERFORMED, AND RESULTS FOR EACH TEST WAS REPORTED AS "NEGATIVE". THE PUMP WAS EXPLANTED AND REPLACED. FOLLOWING THE REPLACEMENT PROCEDURE, THE PATIENT RECOVERED WITHOUT SEQUELA. ADDITIONAL INFORMATION 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 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention CATHETER: MODEL 8709SC, LOT# N150425035.| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N150425035| IMPLANTED:| EXPLANTED: