BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4093346 · Received September 16, 2014

    Report

    Report Number
    3004209178-2014-17111
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    August 21, 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
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER; PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THEIR HEALTHCARE PROVIDER (HCP) ON (B)(6) 2014 WITH NEW ONSET OF SACROILIAC JOINT (SIJ) PAIN (RIGHT GREATER THAN LEFT), ¿FLAIR UP¿ OF CHRONIC PAIN IN THE LOW BACK, AND RADICULAR LEG PAIN AT 8/10. IT WAS NOTED THAT THE PATIENT HAD X-RAYS OF THE CERVICAL SPINE ON (B)(6) 2014, AND A ¿LUMBAR STUDY¿ ON AN UNSPECIFIED DATE. THE HCP PLANNED A RIGHT INTRA-ARTICULAR SACROILIAC INJECTION. INTRATHECAL PUMP REPROGRAMMING WAS PERFORMED; THE DAILY DOSE OF ¿EACH MEDICATION¿ WAS CHANGED BY AN 8 PERCENT INCREASE TO 5.266 MG/DAY. IT WAS EXPECTED THAT THE NEXT INTRATHECAL PUMP REFILL WOULD BE DUE ON OR BEFORE(B)(6) 2014. THE PATIENT WAS TO FOLLOW UP IN 4 WEEKS. ADDITIONALLY, THE PATIENT PRESENTED TO THE HCP ON (B)(6) 2014 DUE TO A SIGNIFICANT INCREASE IN ¿LBP¿ (LOW BACK PAIN) OVER THE PRIOR FEW WEEKS, AND THE PATIENT WAS ANTALGIC WITH WALKER. IT WAS NOTED THAT ELECTIVE REPLACEMENT INDICATOR (ERI) WAS LESS THAN 1 MONTH AWAY AND THE PATIENT WAS TO UNDERGO MEDICAL EVALUATION IN ANTICIPATION OF THE PUMP REPLACEMENT. THE PUMP NOTED AS SECURE IN THE LEFT LOWER ABDOMINAL REGION. THE PATIENT WAS TO FOLLOW UP IN 2-3 DAYS. THE PUMP WAS BEING USED TO DELIVER MORPHINE AND BUPIVACAINE. ADDITIONAL INFORMATION LATER REPORTED THAT THE PATIENT WAS SEEN ON(B)(6) 2014 FOR REPROGRAMMING. IT WAS NOTED THAT THE IMPLANTATION SITES WERE SATISFACTORY IN APPEARANCE. ON PHYSICAL EXAMINATION MOTOR STRENGTH, COORDINATION AND SENSATION WERE INTACT USING WALKER FOR STABILIZATION. IT WAS REPORTED THAT THE PLAN WAS TO REPLACE THE PUMP AT END OF LIFE (EOL) AND ON (B)(6) 2014 THE PUMP WAS REPLACED FOR EOL. THE PATIENT RECEIVED VANCOMYCIN 500MG INTRAVENOUSLY ON-CALL TO THE OPERATING ROOM. THE PUMP WAS COMPLETELY MOBILIZED AND THE CATHETER WAS PRESERVED ENABLING THE CATHETER TO BE EASILY DISCONNECTED AFTER A SIDEPORT ASPIRATION WAS PERFORMED. APPROXIMATELY 0.5ML OF CLEAR CEREBRAL SPINAL FLUID (CSF) WAS OBTAINED WHICH WAS NOT ENOUGH TO CONSIDER DIRECT CONNECTION TO THE NEW PUMP. THE NEW PUMP WAS PURGED AND FILLED WITH A MIXTURE OF BUPIVACAINE AND MORPHINE AT THE SAME CONCENTRATIONS AS HAD BEEN PREVIOUSLY DELIVERED. A BACK TABLE PRIME WAS DONE. THE EXPLANTED PUMP WAS DISCONNECTED FROM THE INTRATHECAL CATHETER AND PLACED ON THE BACK TABLE. AFTER A BACK TABLE PRIME WAS COMPLETED, THE POUCH WAS SECURED AROUND THE PUMP AND THEN THE PUMP WAS CONNECTED TO THE "IN-SITU SUTURELESS CONNECTOR" AND THE PUMP WAS SECURED. POST OPERATIVELY ON (B)(6) 2014, ON PHYSICAL EXAMINATION MOTOR STRENGTH, COORDINATION AND SENSATION WERE INTACT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PUMP WAS REPLACED DUE TO NORMAL BATTERY DEPLETION. THERE WAS NO INDICATION OF A CATHETER ISSUE IN THE REPORT OR CLINICAL NOTES. THE PATIENT WAS SEEN LAST WEEK AND LOOKS GREAT. THE PATIENT IS DOING THE BEST THEY EVER HAD WITH THE NEW PUMP AND IS GETTING EXCELLENT THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571906 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1