BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 6332949 · Received February 15, 2017

    Report

    Report Number
    3007566237-2017-00685
    Event Type
    Injury
    Date Received
    February 15, 2017
    Date of Event
    December 16, 2016
    Report Date
    March 21, 2017
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. 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.

    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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    VAN TILBURG, CORNELIS W.J. INTRATHECAL ANALGESIC DRUG DELIVERY IS EFFECTIVE FOR ANALGESIA IN A PATIENT WITH POST-POLIOMYELITIS SYNDROME: A CASE REPORT. AMERICAN JOURNAL OF CASE REPORTS. 2016. 17: 957-962 DOI: 10.12659/AJCR.901157 SUMMARY: AFTER 8 MONTHS, RELOCATION OF THE PUMP DUE TO REGIONAL PRESSURE PROBLEMS WITH SURROUNDING ERYTHEMA HAD TO OCCUR. A SECOND PUMP RELOCATION DUE TO PRESSURE PROBLEMS AND SKIN EROSION WAS NEEDED 18 MONTHS AFTER THE FIRST RELOCATION, MOVING FROM THE ABDOMINAL WALL TO THE SHEATH OF THE RECTUS ABDOMINIS MUSCLE, RESULTING IN RESOLUTION OF THE PROBLEMS. REPORTED EVENTS: INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A LITERATURE REPORT REGARDING A PATIENT RECEIVING MORPHINE (2 MG/ML AT 1.68 ML/DAY) VIA AN IMPLANTABLE INFUSION PUMP. THE PATIENT'S MEDICAL HISTORY INCLUDED POST=POLIOMYELITIS SYNDROME (PPS), WHEELCHAIR BOUND, AND CHRONIC PAIN. IT WAS REPORTED EIGHT MONTHS AFTER IMPLANT THE PATIENT WAS SEEN BECAUSE OF SKIN PROBLEMS AT THE PUMP POCKET DUE TO REGIONAL PRESSURE RESULTING FROM ABNORMAL POSTURE IN A WHEELCHAIR-BOUND SITUATION, LEADING TO SURROUNDING ERYTHEMA AT THE SITE OF THE PUMP RESERVOIR. IT WAS DECIDED TO RELOCATE THE PUMP RESERVOIR FROM THE LEFT TO THE RIGHT ABDOMINAL WALL. THE RELOCATION WENT SMOOTHLY AND WITHOUT DIFFICULTIES. EIGHTEEN MONTHS AFTER THE RELOCATION, THE PATIENT WAS SEEN AGAIN BECAUSE OF SKIN PROBLEMS DUE TO REGIONAL POSTURAL PRESSURE (LETTING HER ARM REST ALMOST CONTINUOUSLY ON HER BELLY). BECAUSE OF SKIN EROSION, THE PUMP RESERVOIR WAS EXPOSED TO OPEN AIR, THEY DECIDED ON A SECOND RELOCATION, MOVING TOWARDS THE LEFT RECTUS ABDOMINIS MUSCLE SHEATH, A PROCEDURE JOINTLY PERFORMED WITH ONE OF THEIR SURGEONS. THE PROCEDURE TURNED OUT TO BE A SUCCESS AND FURTHER FOLLOW-UP WAS UNEVENTFUL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A DEVICE MANUFACTURER REPRESENTATIVE INDICATED THE PATIENT WAS KNOWN SINCE (B)(6) 2011. THE IDDS (INTRATHECAL DRUG DELIVERY SYSTEM) PROCESS WAS STARTED AND STATUS AFTER POLIOMYELITIS AT THE AGE OF (B)(6). THE PATIENT'S HISTORY ALSO INCLUDED 'MS. HEARING LOSS.' THE PATIENT'S PAIN AREA WAS THE WHOLE BODY BUT MAINLY THE LOWER BACK AND RADIATION TO THE LEFT LEG. THE GOAL WAS REDUCTION OF PAIN, TO BE ABLE TO SIT LONGER IN THE WHEELCHAIR AND IMPROVE SLEEP. THE PATIENT HAD UNDERWENT SEVERAL ORTHOPEDIC BACK SURGERIES. THE INITIAL TRIAL WAS POSTPONED BECAUSE OF DISTAL FEMUR AND IMPLANTATION OF HEARING AID. ON (B)(6) 2013 THE IDDS TRIAL WAS STARTED WITH MORPHINE 2MG/ML. THE END OF THE TRIAL NRS 2, WITH A DAILY DOSE OF MORPHINE OF 3.36 MG/DAY. THE PUMP AND CATHETER WERE IMPLANTED ON (B)(6) 2013. ON (B)(6) 2014 THE PUMP WAS REMOVED AND REPLACED TO THE RIGHT BECAUSE OF PRESSURE ULCERS POCKET. DUE TO INCREASINGLY SHORTER PERIODS BETWEEN REFILLS AND THE CONCENTRATION WAS ADJUSTED TO MORPHINE 10 MG/ML. ON (B)(6) 2015 THERE AGAIN WAS DECUBITIS AT THE PUMP SITE. THE PUMP WAS REMOVED AND TEMPORARILY SWITCHED TO A DIFFERENT MANUFACTURER'S EXTERNAL PUMP. FIRST WOUND HEALING AND THEN A NEW PUMP. ON (B)(6) 2015 A NEW PUMP WAS IMPLANTED IN THE RECTUS SHEATH WITH THE CATHETER PUMP SEGMENT REVISED, THE SPINAL PART REMAINED IN PLACE. NO FURTHER COMPLICATIONS WERE ANTICIPATED/REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116237 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention