BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3932419 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-12970
    Event Type
    Injury
    Date Received
    July 14, 2014
    Report Date
    February 21, 2020
    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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8596SC, SERIAL# (B)(4), IMPLANTED: 2014 (B)(6), EXPLANTED: 2014 (B)(6); PRODUCT TYPE CATHETER PRODUCT ID 8711, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), EXPLANTED: 2014 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    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 REPORTED THAT THE PATIENT WAS ¿NOT GETTING PAIN RELIEF¿ AND HAD ¿LESS THAN 50% THERAPY RELIEF¿. THE PHYSICIAN PERFORMED AN INDIUM STUDY AND DECIDED TO REPLACE THE CATHETER. UPON REPLACEMENT, THE PHYSICIAN THOUGHT THE CATHETER WAS OCCLUDED IN THE SPINE INCISION WHERE THE PIN CONNECTED THE TWO PIECES OF CATHETERS. HE ATTRIBUTED THE OCCLUSION TO SCAR TISSUE BUILD UP NEAR AND AROUND THE PIN CONNECTOR. THE PATIENT¿S STATUS WAS ¿ALIVE ¿ NO INJURY¿. THE DEVICE SYSTEM WAS USED TO DELIVER HYDROMORPHONE, CLONIDINE AND BUPIVACAINE. ADDITIONAL INFORMATION INDICATED THAT THERE WERE NO SEGMENTS LEFT IN THE INTRATHECAL SPACE. FOLLOWING THE REPLACEMENT, THE PATIENT WAS RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410803 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention