BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2201770 · Received August 5, 2011

    Report

    Report Number
    3004209178-2011-06102
    Event Type
    Injury
    Date Received
    August 5, 2011
    Report Date
    July 16, 2011
    Manufacturer
    MEDTRONIC 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

    IT WAS REPORTED THAT A PATIENT INFECTION OCCURRED. A REFILL WAS DELAYED DUE TO THE INFECTION. THE PATIENT'S PUMP WAS NOTED AS STILL BEING IN SERVICE. THE PUMP WAS IMPLANTED ON (B)(6) 2009. THE PUMP WAS REPLACED ON (B)(6) 2011. AFTER THE REPLACEMENT, THE INFECTION CLEARED. THE REASON FOR THE REPLACEMENT WAS THAT THE PUMP HAD ERODED AND BECAME INFECTED. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS DILAUDID. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATHETER: MODEL 8709, LOT# J11502R36| EXPLANTED:| IMPLANTED: