BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5571628 · Received April 12, 2016

    Report

    Report Number
    3004209178-2016-07304
    Event Type
    Injury
    Date Received
    April 12, 2016
    Date of Event
    September 14, 2012
    Report Date
    May 20, 2016
    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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: CATHETER. PRODUCT ID: 8590-1, LOT# N242813, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: ACCESSORY.

    Additional Manufacturer Narrative · 1

    PATIENT CODE NO LONGER APPLIES TO THE EVENT. CONCLUSION CODE APPLIES TO THE PUMP, SERIAL # (B)(4). CONCLUSION CODE APPLIES TO THE CATHETER, SERIAL # (B)(4). 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

    CONCOMITANT PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. PRODUCT ID: 8590-1, LOT# N242813, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT IN A CLINICAL STUDY WHO WAS RECEIVING MORPHINE WITH CONCENTRATION 25.0 MG/ML AT A DOSE RATE OF 4.902 MG/DAY VIA AN IMPLANTABLE PUMP AS OF (B)(6) 2011 FOR NON-MALIGNANT PAIN AND FAILED BACK SURGERY SYNDROME. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A GRADUAL LOSS OF EFFECT OF TREATMENT. WHEN PALPATED ON (B)(6) 2012, THE PUMPED MOVED FREELY IN THE POCKET. THIS WAS DUE TO THE LARGE AMOUNT OF WEIGHT THE PATIENT HAD LOST. THE CLINICAL DIAGNOSIS WAS PUMP INVERSION. THE CATHETER WAS TWISTED. THE PROGRAMMING DATE FROM THE MOST RECENT REFILL PRIOR TO THE EVENT OCCURRED ON (B)(6) 2012. THE PATIENT WAS RECEIVING INFUMORPH VIA THEIR PUMP AT THE TIME OF THE EVENT. THE EVENT HAD RESULTED IN AN UNSCHEDULED CLINIC / OFFICE VISIT. INTERVENTION INCLUDED THE PUMP HAVING BEEN REPOSITIONED ON (B)(6) 2012. THE EVENT RESOLVED WITHOUT SEQUELAE AS OF (B)(6) 2012. REGARDING ETIOLOGY, THE EVENT WAS NOT RELATED TO THE DEVICE OR THERAPY BUT WAS RELATED TO THE IMPLANT PROCEDURE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CLINICAL SITE INDICATED THE ENTIRE CATHETER WAS ALSO REMOVED ON (B)(6)-2012 DURING THE PUMP RE-POSITIONING. THE LOCATION OF THE EXPLANTED CATHETER WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225150 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR Required Intervention