BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5764799 · Received July 1, 2016

    Report

    Report Number
    3004209178-2016-13358
    Event Type
    Injury
    Date Received
    July 1, 2016
    Date of Event
    January 1, 2012
    Report Date
    January 27, 2018
    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
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. 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.

    Additional Manufacturer Narrative · 1

    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.

    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 WRITTEN COMPLAINT FILED IN COURT BY AN ATTORNEY FOR A PATIENT WHO ALLEGEDLY RECEIVED BACLOFEN VIA AN IMPLANTABLE INFUSION PUMP IMPLANTED IN (B)(6) 2010. THE INDICATION FOR USE (IFU) WAS LISTED AS INTRACTABLE SPASTICITY AND CEREBRAL PALSY. THE COMPLAINT ALLEGES THAT, FOR SEVERAL MONTHS AFTER IMPLANT, THE PATIENT¿S SPASTICITY IMPROVED INTERMITTENTLY. BY EARLY 2012, THE EFFICACY OF THE DEVICE ALLEGEDLY STARTED TO NOTICEABLY DECREASE AND THE PATIENT PURPORTEDLY ¿BEGAN EXPERIENCING INCREASED MUSCLE TIGHTNESS, RIGIDITY, AND PAIN, LEADING TO SIGNIFICANTLY DECREASED MOBILITY.¿ THE COMPLAINT FURTHER ALLEGES THAT, IN (B)(6) 2012, AFTER REVIEW OF LABORATORY AND RADIOGRAPHIC STUDIES IT WAS DETERMINED THAT THE DEVICE MALFUNCTIONED DUE TO AN OCCLUSION OF THE INTRATHECAL CATHETER. AS A RESULT OF THE MALFUNCTION, THE DEVICE ALLEGEDLY FAILED TO DELIVER THE PRESCRIBED MEDICATION AS PROGRAMMED. THE MALFUNCTION PURPORTEDLY RESULTED IN THE MEDICATION DELIVERED INTERMITTENTLY, MEDICATION ¿DUMPS¿ DELIVERING TOO MUCH MEDICATION, OR A COMPLETE FAILURE TO DELIVER MEDICATION, CAUSING SEVERE DAMAGE AND INJURY TO THE PATIENT. THE COMPLAINT FURTHER ALLEGES, ¿ON (B)(6) 2012, THE PATIENT UNDERWENT A PROCEDURE TO REPLACE THE INTRATHECAL CATHETER¿ AND ¿THE OPERATIVE FINDING WAS A ¿MALFUNCTIONING INTRATHECAL PORTION OF PUMP.¿ THE COMPLAINT ALSO ALLEGES THE PATIENT WAS HOSPITALIZED FOR SEVEN DAYS WITH POSTOPERATIVE PAIN, IMMOBILITY, AND SEVERE NAUSEA. THE LAWSUIT SEEKS COMPENSATION FOR THE PATIENT¿S ALLEGED PERSONAL INJURIES, PAIN, SUFFERING, MENTAL AND EMOTIONAL ANGUISH, LOSS OF EARNINGS AND FUTURE EARNING CAPACITY, MEDICAL EXPENSES, AND OTHER DAMAGES.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THERE WAS A CATHETER FAILURE AND THE PATIENT EXPERIENCED SPASTICITY AND UNDERINFUSION. THE DATE OF INJURY WAS NOTED AS UNDER INVESTIGATION. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419194 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization| R