BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3021440 · Received March 26, 2013

    Report

    Report Number
    3004209178-2013-04243
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 26, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS EXPLANTED DUE TO AN INFECTION OF THE POCKET. IT WAS ALSO NOTED THAT THERE WERE NO PATIENT SYMPTOMS OR INJURIES RELATED TO THIS EVENT. THE DRUG USED IN THIS SYSTEM WAS UNKNOWN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: PER THE HCP THE TEST OF THE CULTURE WAS NEGATIVE (NO INFECTION FOUND).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122967 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00032 YR Required Intervention