BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4251970 · Received November 14, 2014

    Report

    Report Number
    3004209178-2014-21642
    Event Type
    Injury
    Date Received
    November 14, 2014
    Report Date
    October 23, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. PRODUCT ID: 8703W, LOT# L78720, IMPLANTED: (B)(6) 2000, PRODUCT TYPE: CATHETER. PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT BOTH THE PUMP AND SPINAL CATHETER SEGMENTS WERE CONFIRMED TO HAVE BEEN EXPLANTED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD PROGRESSIVE PAIN. THE PATIENT WAS EXAMINED/ PALPATED AS A DIAGNOSTIC ON (B)(6) 2014, BECAUSE THE PAIN WAS PROGRESSIVE DESPITE PUMP INCREASES. FLUOROSCOPY DETERMINED THAT THE CATHETER WAS OCCLUDED ON (B)(6) 2014. THEY WERE UNABLE TO ASPIRATE THE CEREBRAL SPINAL FLUID (CSF) OR INJECT CONTRAST. THE ETIOLOGY WAS REPORTED AS DUE TO THE ¿ENTIRE CATHETER¿-SERIAL NUMBER (B)(4) (PUMP SEGMENT), AND THAT THE ISSUE WAS RELATED TO THE DEVICE OR THERAPY, AND NOT RELATED TO THE IMPLANT PROCEDURE. THE ¿ENTIRE¿ CATHETER WAS REPLACED ON (B)(6) 2014, AND THE LOCATION OF THE OCCLUSION WAS UNKNOWN. THE SEVERITY OF THE EVENT WAS SAID TO BE MODERATE. THE OUTCOME WAS REPORTED AS RESOLVED WITHOUT SEQUELA AS OF (B)(6) 2014. THE PUMP WAS INFUSING DILAUDID, BUPIVACAINE, AND CLONIDINE. IT WAS UNCLEAR WHICH SEGMENT WAS REPLACED, AS THE MANUFACTURER¿S IMPLANT RECORDS SHOW THE PATIENT ALSO HAD A SPINAL SEGMENT IMPLANTED AT THE TIME OF THE EVENT, WHICH WAS NOT REPORTED TO HAVE BEEN REPLACED, DESPITE ALLEGATIONS THAT THE ¿ENTIRE CATHETER¿ WAS REPLACED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736857 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention