BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3900722 · Received June 27, 2014

    Report

    Report Number
    3004209178-2014-12222
    Event Type
    Injury
    Date Received
    June 27, 2014
    Report Date
    June 6, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1060-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, LOT# J10961R19, IMPLANTED: 2001 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A POCKET FILL DURING A REFILL. IT WAS NOT KNOWN WHEN THIS HAD OCCURRED, BUT DID OCCUR WHILE UNDER THE CARE OF ANOTHER PHYSICIAN. THE PHYSICIAN WAS NOT AWARE OF THE POCKET FILL AT THE TIME OF THE POCKET FILL. IT WAS NOT KNOWN WHAT MEDICATIONS THE DEVICE SYSTEM DELIVERED AT THE TIME OF THE EVENT. HOWEVER, A HEALTHCARE PROVIDER BELIEVED THERE WERE SIX DIFFERENT DRUGS IN THE PUMP AT THE TIME. IT WAS UNCLEAR IF THE PATIENT HAD OVERDOSE SYMPTOMS; HOWEVER, THE PATIENT DID HAVE WITHDRAWAL SYMPTOMS SINCE THE PUMP RESERVOIR WAS EMPTY DUE TO THE POCKETFILL. DUE TO THE PUMP RESERVOIR BEING UPDATED TO A NORMAL REFILL AMOUNT, THE LOW/EMPTY RESERVOIR ALARMS NEVER ACTIVATED AT THAT TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378315 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Other