BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2162068 · Received July 12, 2011

    Report

    Report Number
    3004209178-2011-05325
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    April 13, 2011
    Report Date
    June 20, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DECREASED THERAPEUTIC BENEFIT. THE PATIENT HAD HIS CATHETER REPLACED ON (B)(6) 2011, FOLLOWING WHICH THE PATIENT HAD AN INFECTION AT THE INCISION SITE. SYMPTOMS OF INFECTION INCLUDED REDNESS AND BLISTERING AT THE BACK INCISION. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2011. THE CATHETER WAS EXPLANTED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization| R IMPLANTED:| CATHETER: MODEL 8711, LOT# J0058149R| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N281307002| EXPLANTED:| IMPLANTED: