BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3122633 · Received May 21, 2013

    Report

    Report Number
    3004209178-2013-07988
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    April 24, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO DEVICE ISSUE, ¿IT WAS ALL POST-SURGICAL COMPLICATIONS.¿ THE PREVIOUSLY REPORTED ¿WATER¿ AROUND THE PUMP WAS ALSO REFERRED TO AS ¿A BLOOD CLOT OR SOMETHING¿ THAT, AS PREVIOUSLY REPORTED, HAD TO BE DRAINED. IT WAS NOTED THAT THE PATIENT WAS ¿FINE¿ NOW BUT ¿THAT BUMP WOULD NOT GO DOWN.¿ IT WAS NOTED THAT THE BUMP WAS ¿THE SIZE OF A SOCCER BALL.¿

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD TO GO TO THE EMERGENCY ROOM (ER) BECAUSE SHE ¿WASN¿T GETTING ANY MEDICINE,¿ THE REPORTER ¿REALLY COULDN¿T¿ REMEMBER THE DATE OF ER VISIT. THE PATIENT REPORTED THAT THE ¿CAPS WEREN¿T ON GOOD ENOUGH; LIKE THEY CAME LOOSE OR SOMETHING,¿ IT WAS NOT CLEAR WHAT WAS MEANT BY THIS. THE ISSUE WAS FIXED WITH SURGERY AS PREVIOUSLY REPORTED. THE PATIENT HAD PIECE OF PAPER WITH THE DATE (B)(6) 2013, SHE HAD ¿THE ONE BAG, THE COCCYDYNIA, MULTIPLE SCLEROSIS, FIBRO CERVICALGIA, ARM AND LEG PAIN, PERITONITIS, AND A CSF (CEREBROSPINAL FLUID) LEAK.¿ IT WAS NOT CLEAR IF THAT LIST WAS HEALTH HISTORY OR ISSUES CURRENT AT THE TIME THE PAPER WAS PRINTED, IT WAS ALSO UNCLEAR IF THEY WERE RELATED TO THE DEVICE OR THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD ¿WATER¿ AROUND THE PUMP. THE POCKET HAD TO BE DRAINED TWO OR THREE TIMES. A COMPUTER ASSISTED TOMOGRAPHY SCAN WAS TAKEN, AND IT WAS FOUND THAT THE CATHETER WAS LEAKING. THE PATIENT HAD A SURGERY IN FEBRUARY TO FIX THE CATHETER LEAK, WHICH RESOLVED. THE DRUGS IN THE PUMP WERE BACLOFEN AND MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD "COCCYDYNIAIN" HER LOWER SPINE AS PREVIOUSLY REPORTED AND IT WAS NOTED THE PATIENT HAD ¿FIBROMYALGIA, MS AND ABOUT 15 OTHER THINGS TOO¿. RELATED TO THE ¿CAPS COMING LOOSE¿ THAT WAS PREVIOUSLY REPORTED, THE PATIENT WAS HAD BEEN IN EXCRUCIATING PAIN AND IT WAS CONFIRMED THEY HEALTH CARE PROVIDER (HCP) ¿FIXED IT, I THINK IT WAS IN (B)(6) 2013¿.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED ON (B)(6) 2013 A ¿CSF (CEREBROSPINAL FLUID) LEAK-MALFUNCTION/COMPLICATION OF THE DEVICE¿ ALSO REFERRED TO AS A CATHETER LEAK OCCURRED. AS PREVIOUSLY REPORTED THE PATIENT HAD TO GO BACK IN FOR REPAIR SO THE CATHETER DIDN¿T LEAK. IT WAS ALSO REPORTED FLUID WAS AROUND THE PATIENT¿S PUMP AS WELL AS HER BACK. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE CATHETER HAD DISCONNECTED FROM THE PIN CONNECTOR. THE CATHETER WAS AGAIN NOTED TO HAVE BEEN LEAKING WAS REPORTEDLY REPLACED AS A RESULT. THE DEVICE HAD DELIVERED MORPHINE, BUPIVACAINE AND NEURONTIN AT THE TIME OF THE EVENT. NO FURTHER INFORMATION WAS PROVIDED INCLUDING THE CAUSE OF THE EVENT OR IF ANY OTHER ACTIONS OCCURRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223873 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention