BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1943906 · Received December 28, 2010

    Report

    Report Number
    3004209178-2010-10805
    Event Type
    Injury
    Date Received
    December 28, 2010
    Date of Event
    December 15, 2010
    Report Date
    December 15, 2010
    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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE SYSTEM WAS EXPLANTED DUE TO INFECTION. ADDITIONAL INFO 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 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other EXPLANTED:| CATHETER: MODEL 8709SC, LOT #: N172218001| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8596SC, LOT #: N177049018| IMPLANTED: