BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2904939 · Received January 9, 2013

    Report

    Report Number
    3004209178-2013-00385
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 14, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8709 LOT# SERIAL# (B)(4), IMPLANTED: 2005 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID, 8596SC LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE HCP WAS PERFORMING A CATHETER REPLACEMENT PROCEDURE AND DISCOVERED AN ENCAPSULATED MASS IN THE SPINE. WHEN HE OPENED IT 'POSSIBLE PUS' WAS RUNNING OUT. HE TRIED TO REMOVE THE MASS AND THEN REALIZED ADDITIONAL REMOVAL SHOULD BE DONE BY A NEUROSURGEON. THE HCP SUSPECTED THAT THE DRUG WAS NEVER FLOWING INTO THE PATIENT'S SPINE BECAUSE, THE IN-SITU CATHETER WAS RUNNING THROUGH THE MASS. THE SPECIMEN WAS SENT TO PATHOLOGY. EVERYTHING WAS EXPLANTED IN CASE OF INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED, THE CATHETER HAD A BREAK, TEAR, OR HOLE IN THE DISTAL/SPINAL SEGMENT. A SUBCUTANEOUS GRANULOMA WAS NOTED TO HAVE RESULTED DUE TO "DRUG EFFECTS"; THE GRANULOMA WAS OUTSIDE OF THE PATIENT'S SPINE. THE PATIENT WAS NOTED TO HAVE RECOVERED WITHOUT SEQUELA AND WAS DOING "OK" ACCORDING TO THEIR HEALTHCARE PROVIDER. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS SUBMISSION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF FURTHER INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11204 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention