BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2223795 · Received August 18, 2011

    Report

    Report Number
    3004209178-2011-06524
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 25, 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
    NC, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD HIS PUMP REMOVED AS IT WAS CAUSING "A HOLE THROUGH THE SKIN WHERE PUMP WAS LOCATED." IT WAS ALSO STATED THAT THE PUMP WAS "LEAKING". PT "HOPED TO GET ANOTHER PUMP THAT WAS SMALLER THAN WHAT HE HAD." A F/U REPORT WILL BE SENT IF ADD'L 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 46 YR Male Hospitalization| R CATHETER: MODEL 8703W, LOT# L56469| EXPLANTED: | IMPLANTED: | CATHETER: MODEL 8703W, LOT# L56469| EXPLANTED:| IMPLANTED: