BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3223771 · Received July 12, 2013

    Report

    Report Number
    3004209178-2013-11680
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    June 19, 2013
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_UNKNOWN_CATH LOT# UNKNOWN, EXPLANTED: 2012 (B)(6); PRODUCT TYPE CATHETER PRODUCT ID: 8711 LOT# SERIAL# (B)(4), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE OVERALL ASSESSMENT OF CONTINUOUS ADMINISTRATION WAS EFFECTIVE, AS THE¿ TENDON REFLEX CLONUS¿ WAS REDUCED AND THUS IT WAS DETERMINED IMPROVEMENT HAD BEEN MADE. THE PREVIOUSLY REPORTED CATHETER REPLACEMENT DATE WAS (B)(6)-2013. ANOTHER SURGICAL DATE WAS PROVIDED AS (B)(6)-2013, THUS IT WAS UNSURE WHICH OF THESE DATES WERE CORRECT.

    Description of Event or Problem · 1

    IT WAS REPORTED CATHETER DISLODGEMENT OCCURRED ON 2012 (B)(6). THE CATHETER WAS REPLACED ON 2012 (B)(6) DUE TO THE MIGRATION. THE PATIENT¿S OUTCOME FROM THE EVENT WAS REPORTEDLY ¿RECOVERED¿ AS OF 2012 (B)(6). IT WAS THEN REPORTED ON 2012 (B)(6), THE PATIENT¿S DRUG EFFICACY WAS REDUCED. THEN ON 2012 (B)(6), CATHETER DISLODGEMENT OCCURRED AGAIN AS WELL AS MIGRATION. EXAMINATION REVEALED THE MIGRATION AND IT WAS NOTED ¿DRUG ADMINISTRATION WAS INTERRUPTED¿. THE REASON FOR THE MIGRATION WAS UNKNOWN; THE CATHETER HAD MIGRATED INTO THE EPIDURAL SPACE WHICH RESULTED IN THE ¿SAME CONDITION AS BEFORE OPERATION¿. THE EVENT RESULTED IN REQUIRING HOSPITALIZATION OR PROLONGATION OF HOSPITALIZATION. TERMINATION OF THE LONG-TERM CONTINUOUS ADMINISTRATION OCCURRED ON 2012 (B)(6) DUE TO AN ONSET OF AN ADVERSE EVENT. ¿IT WAS ADJUDGED THAT CONTINUED ADMINISTRATION WOULD BE INEFFECTIVE DUE TO CATHETER DISLODGEMENT¿. IT WAS NOTED ¿THE CASE WAS DETERMINED AS NO ADVERSE EVENT BECAUSE, THE PATIENT¿S SYMPTOMS WERE THE SAME PRIOR TO IMPLANTATION WITHOUT ANY SIGN OF WITHDRAWAL SYMPTOMS¿. SEVERAL DOSE ADJUSTMENTS HAD OCCURRED, FROM 2012 (B)(6) THROUGH 2012 (B)(6), FOR SPASM CONTROL. THEN ON 2012 (B)(6), THE PUMP WAS CHANGED TO MINIMAL RATE, THE REASON BEING ¿INJECTION DISCONTINUED¿. REPORTEDLY AT THE PATIENT¿S REQUEST, THE OPERATION WAS SCHEDULED FOR ¿(B)(6) OR LATER¿. IT WAS THEN REPORTED ON 2013 (B)(6) ¿AFTER OBSERVATION, CATHETER WAS REPLACED¿. THE PATIENT¿S OUTCOME FOLLOWING THE SECOND CATHETER DISLODGEMENT WAS UNKNOWN. IT WAS NOTED AN OVERALL ASSESSMENT OF THE PATIENT¿S LONG TERM CONTINUOUS ADMINISTRATION 12 MONTHS POST IMPLANTATION WAS PERFORMED WHICH REVEALED THE PATIENT¿S CLONUS WAS REDUCED ¿SO IT WAS DETERMINED THAT IMPROVEMENT HAD BEEN MADE¿ HOWEVER, THE TIME FRAME OF THE ASSESSMENT WAS NOT PROVIDED. AS OF 2013 (B)(6), THE PATIENT OUTCOME WAS THEN REPORTED AS RECOVERED. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. IT WAS NOTED, THE PUMP WAS IMPLANTED IN 2011 (B)(6), HOWEVER, THIS WAS CONFLICTING INFORMATION AS THE DEVICE MANUFACTURING DATE WAS 2012-02-04 AND PER THE DEVICE MANUFACTURER IMPLANT REGISTRY THE PUMP WAS LISTED AS IMPLANTED ON 2012 (B)(6).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IN REGARDS TO THE SECOND CATHETER (SERIAL # (B)(4)) REPLACEMENT DATE IT WAS CLARIFIED TO HAVE BEEN REPLACED ON (B)(4) 2013. PATIENT OUTCOME WAS NOTED TO BE RECOVERED AS OF(B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321769 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Hospitalization| R