BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2871834 · Received December 13, 2012

    Report

    Report Number
    3004209178-2012-11797
    Event Type
    Injury
    Date Received
    December 13, 2012
    Report Date
    November 16, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER MODEL: 8731SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: UNK. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT DOCTOR DID NOT GIVE PATIENT ANY ANTIBIOTICS. PATIENT HAD HOLES A SIZE OF PENNY WHERE THE INCISION SITE WAS AND THE PATIENT COULD SEE THE PUMP AND CATHETER. THE PUMP WAS USED TO DELIVER DILAUDID.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS REPLACED DUE TO AN INFECTION. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Required Intervention