BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3693539 · Received March 21, 2014

    Report

    Report Number
    3004209178-2014-04838
    Event Type
    Injury
    Date Received
    March 21, 2014
    Date of Event
    November 13, 2012
    Report Date
    March 18, 2014
    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
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8578, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY; PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED CATHETER (INCOMPLETE IN SEGMENTS) REVEALED NO SIGNIFICANT ANOMALY - ACCEPTABLE TESTING. THERE WAS A NO N-SIGNIFICANT DENT IN THE SEAL THAT DID NOT AFFECT INFUSION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT'S PUMP WAS USED TO INFUSE BACLOFEN MONO-THERAPY UNTIL 2013-(B)(6). IT WAS NOTED THAT FROM 201 3-02-25 TO 2013-(B)(6) THE PATIENT¿S PUMP WAS USED TO INFUSE BACLOFEN AND MORPHINE. IT WAS REPORTED THAT FROM 2013-(B)(6) TO THE TIME OF REPORT THE PATIENT PUMP WAS USED TO INFUSE BACLOFEN MONO-THERAPY.

    Description of Event or Problem · 1

    THE PATIENT REPORTED YESTERDAY TO THE REPRESENTATIVE THAT OVER THE LAST YEAR THEY HAD EXPERIENCED INCREASED TIGHTNESS IN THEIR LEGS AND MORE TIGHTNESS IN THEIR UPPER EXTREMITIES. AT SOME POINT THE PATIENT WAS PROGRAMMED WITH A BOLUS OF 125 MCG AND THERE WAS NO RESPONSE. A DYE STUDY WAS DONE YESTERDAY. NO ANOMALIES WERE FOUND, AND THE CATHETER APPEARED TO BE INTRATHECAL. THE CATHETER WAS PRIMED AFTER THE DYE STUDY. FOLLOWING THE DYE STUDY THE PATIENT WAS GOING TO HAVE AN MRI AND CT FOR FURTHER SYSTEM EVALUATION. THE MEDICATIONS INFUSED WERE BACLOFEN AND MORPHINE. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THERE WAS NO DEVICE ISSUE. THE PATIENT WAS RETURNED TO BACLOFEN MONOTHERAPY AND WAS MUCH IMPROVED. IT WAS LATER REPORTED THAT THE PATIENT HAD EXPERIENCED INCREASED SPASTICITY IN THE LEGS AND ARMS AND LESS THAN 50% THERAPEUTIC RELIEF. THE MANAGING PHYSICIAN REACHED OUT TO A SURGEON ON (B)(6) 2014 AS THE PATIENT WAS IN INPATIENT REHABILITATION AND WAS VERY STIFF AND HAD NO RESPONSE TO TWO 75MCG BOLUSES DELIVERED OVER TWO HOURS. THE SURGEON AGREED TO REPLACE THE CATHETER AND THE REPLACEMENT TOOK PLACE ON (B)(6) 2014. NO OBVIOUS ISSUES WERE FOUND INTRA-OPERATIVELY WITH THE FORMER CATHETER. THE NEW CATHETER WAS EASILY ASPIRATED OF CEREBROSPINAL FLUID (CSF) INTRA-OPERATIVELY. THE PATIENT¿S DOSE WAS REDUCED BY 50% POST-OPERATION AND THE PATIENT¿S DOSE WAS TO BE TITRATED AS NEEDED. CONFLICTING INFORMATION AS PROVIDED AS THE REPORT SOURCE STATED THAT THE DEVICE DELIVERED ONLY BACLOFEN. PATIENT STATUS AT THE TIME OF THE REPORT WAS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169776 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention