BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1936186 · Received December 14, 2010

    Report

    Report Number
    3004209178-2010-10443
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 3, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS DROWSY, SHOWING SIGNS OF APNEA AND SHORTNESS OF BREATH. IT WAS UNCERTAIN IF THE SYMPTOMS WERE RELATED TO THE PUMP OR NOT. NO CHANGES TO DOSAGE HAVE BEEN MADE RECENTLY AND THE PT HAD "A NUMBER OF OTHER MEDICAL ISSUES". ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other CATHETER: MODEL 8709SC, LOT# N232675001| IMPLANTED:| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 8590-1, LOT# N231075| EXPLANTED: