BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2200851 · Received August 8, 2011

    Report

    Report Number
    3007566237-2011-06130
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    October 18, 2004
    Report Date
    August 25, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS NOT GETTING GOOD PAIN RELIEF AND "HAD BEEN SICK ABOUT A YEAR WITH NO ANSWERS". SYMPTOMS REPORTED WERE CHANGE IN GAIT, MOTOR WEAKNESS, TINGLING AND NUMBNESS DOWN THE LEGS, OVER THE ENTIRE SYS, FALLEN DOWN "SEVERAL TIMES" RESULTING IN BROKEN ARMS AND RIBS, "WENT FROM RUNNING 12 LAPS AROUND TO GYM TO WALKING WITH A CANE" RIGHT LEG SENSITIVE TO TOUCH, NUMB AND TINGLING. INITIALLY PT WAS AFRAID TO HAVE PUMP REMOVED AS IT WAS HELPING PT'S PAIN, IC PAIN AND LOW PACK PAIN. ON (B)(6) 2011, SHE HAD SURGERY TO REPLACE HER PAIN PUMP BECAUSE OF END OF BATTERY LIFE. DURING SURGERY, IT WAS NOTICED THAT THE CATHETER WAS NOT SUPPLYING THE DRUG TO THE DIRECTED AREA AND WAS EITHER "KINKED OR CLOGGED". PART OF OLD CATHETER WAS LEFT BACK DUE TO ADHESION TO WALL LINING. PT WAS AT HOME AND WAS DOING "GOOD" WITH NEW PUMP BUT WAS ALSO HAVING A REACTION TO THE ABDOMINAL BINDER OVER THE PUMP: SKIN LOOKED SUNBURNED. THE PT WAS TO VISIT THE NURSE ON (B)(6) 2011 REGARDING THIS ISSUE. ON (B)(6) 2011, IT WAS REPORTED THAT THE PT WAS NOT HAVING THERAPEUTIC EFFECT WITH THE NEW PUMP AS WELL. PRIOR TO REPLACEMENT, PT WAS GETTING MORPHINE DOSE WAS 9 MG/DAY; POST SURGERY, STARTING MORPHINE DOSE WAS 3.002 MG/DAY AND NOW THE DOSE WAS 4.7 MG/DAY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER ON (B)(6)-2016 AND IT WAS REPORTED THAT THE PATIENT HAD NEVER GOTTEN GOOD PAIN RELIEF FROM THE PUMP. THEY BELIEVED THAT THE CATHETER WAS OCCLUDED FROM THE TIME OF IMPLANT IN 2004 BECAUSE SHE NEVER HAD THERAPY. IN 2011, A PORTION OF THE PATIENT'S CATHETER HAD TO REMAIN IN HER SIDE BECAUSE DURING THE REPLACEMENT SURGERY THE DOCTOR COULD NOT EXPLANT IT. IT WAS ALSO PREVIOUSLY NOTED THAT DURING THE REPLACEMENT THE CATHETER HAD A BLACK GOBBLE AT THE END OF THE CATHETER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER RECEIVED REPORTED THAT THE DEVICE DID NOT MAKE THE PATIENT'S LIFE BETTER. THE FIRST 7 YEARS GAVE NO RELIEF. PER THE PATIENT NO WONDER. WHEN IT CAME TIME TO EXPLANT IT THE CATHETER WAS FOUND TO BE OCCLUDED WITH ALL THE MEDICINE FILLING A POCKET UNDERNEATH THE PUMP.

    Description of Event or Problem · 1

    INFORMATION WAS LATER RECEIVED FROM A CONSUMER INDICATING THAT THE FIRST PUMP DID NOT WORK, AND A CATHETER OCCLUSION WAS DISCOVERED AT EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention IMPLANTED:| EXPLANTED: