BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2032442 · Received March 25, 2011

    Report

    Report Number
    3004209178-2011-02304
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 10, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PUMP AND CATHETER 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

    THERE WAS AN OPEN WOUND AT THE PUMP SITE. THE IMPLANTED SYSTEM BECAME CONTAMINATED AND WAS EXPLANTED. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THE EVENT. THE PATIENT RECOVERED WITHOUT SEQUELA AFTER REMOVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention CATHETER: MODEL 8575, LOT# J0321911R| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# L56457