BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4130379 · Received September 30, 2014

    Report

    Report Number
    3004209178-2014-18017
    Event Type
    Injury
    Date Received
    September 30, 2014
    Report Date
    September 8, 2014
    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
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER; PRODUCT ID 8 709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER; PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL ASSESSMENT OF THE EVENT NOTED THAT THE EVENT OF RESPIRATORY FAILURE AND SUBSEQUENT HOSPITALIZATION IS NOT RELATED TO THE DEVICE OR THERAPY, AS FOLLOW-UP RECEIVED INDICATES IT WAS A RESULT OF OVER SEDATION FROM ORAL MEDICATIONS. (B)(4). THE PREVIOUSLY REPORTED CONCLUSION CODE NO LONGER APPLIES.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE DIAGNOSIS OF A PARALYZED DIAPHRAGM ON HALF OF THE DIAPHRAGM WAS NOT RELATED TO THE DEVICE OR THERAPY. THE CAUSE OF THE PATIENT¿S EPISODES OF RESPIRATORY FAILURE WAS OVER SEDATION FROM ORAL MEDICATIONS IN PATIENT WITH PULMONARY COMPROMISE.

    Description of Event or Problem · 1

    IT WAS REPORTED A DYE STUDY WAS ATTEMPTED ON THE DAY PRIOR TO THE DATE OF THE REPORT. THE PATIENT HAD BEEN EXPERIENCING EPISODES OF RESPIRATORY FAILURE AT A NURSING HOME SO SHE WAS HOSPITALIZED. THE PATIENT WOULD HAVE EPISODES OF ¿DESATS¿ IN HER OXYGEN ¿SATS.¿ THE PATIENT HAD A DIAGNOSIS OF A PARALYZED DIAPHRAGM ON HALF OF THE DIAPHRAGM. THE HEALTH CARE PROVIDER WANTED TO SEE IF THE HIGH DOSE IN THE PUMP WAS TRULY BEING RECEIVED. THE DOCTOR ORDERED A DYE STUDY TO MAKE SURE THE PUMP WAS DELIVERING MEDICATION. THE DOCTOR WAS UNABLE TO ASPIRATE CEREBROSPINAL FLUID (CSF) FROM THE CATHETER ACCESS PORT (CAP). A ROTOR/ROLLER STUDY WAS ALSO DONE AND THE LOGS WERE CHECKED. THE CAUSE OF THE INABILITY TO ASPIRATE THE CAP WAS NOT DETERMINED. A CATHETER ISSUE WAS NOT IDENTIFIED. NO ADDITIONAL TROUBLESHOOTING, INTERVENTIONS, OR OTHER ACTIONS WERE TAKEN FOLLOWING THE INITIAL REPORT. THE ELECTIVE REPLACEMENT INDICATOR WAS IN 3 MONTHS, SO THE PATIENT WAS BEING REFERRED TO A SURGEON FOR TA PUMP CHANGE AND POSSIBLE CATHETER REVISION. THERE WAS NO CHANGE IN PAIN STATUS. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ¿ALIVE- NO INJURY.¿ THE SYSTEM WAS BEING USED TO DELIVER MORPHINE. THE PATIENT OUTCOME WAS NOT KNOWN AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609190 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L