BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3070743 · Received April 22, 2013

    Report

    Report Number
    3004209178-2013-06635
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    March 25, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID: 8840 LOT# SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THERE WAS A SWELLING OVER THE PUMP. THERE WAS NO DEVICE ISSUE INDICATED. IT WAS ADDED THAT DURING THE DYE STUDY DONE ON (B)(6) 2013 THERE WAS NO LEAKAGE NOTED. CSF FROM TAP GREW ¿SCANT STAPH WARNERI" WITH NORMAL CELL COUNT, GLUCOSE, AND PROTEIN AND NEG GRAM STAIN; BUT A REPEAT TAP DONE ON 6/25/13 SHOWED NO GROWTH ¿SO ASSUMED CONTAMINANT¿. PATIENT HAD LOW PRESSURE, HEADACHE FOR ABOUT A WEEK AFTER PUMP PLACEMENT AND UNDERWENT BLOOD PATCH WHICH RESOLVED PROBLEM. PRESENTLY PATIENT WAS DOING WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PATIENT HAD A DYE STUDY PERFORMED DURING THE WEEK OF (B)(6) 2013. THE HEALTH CARE PROVIDER (HCP) STATED THAT EVERYTHING APPEARED "ALL CONNECTED AND WORKING." HOWEVER, THE HCP STATED THAT WHEN THEY "TAPPED HER" THE CEREBRAL SPINAL FLUID (CSF) HAD "(B)(6)" IN IT. AS A RESULT, THEY WERE "GOING BACK IN" AS THE PATIENT WAS TO HAVE AN ADDITIONAL 3 CC'S OF CSF WITHDRAWN TO FURTHER TEST. THIS DEVICE SYSTEM DELIVERED BACLOFEN. 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
    170999 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00014 YR Other| R