BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4812032 · Received June 2, 2015

    Report

    Report Number
    3004209178-2015-10097
    Event Type
    Injury
    Date Received
    June 2, 2015
    Date of Event
    April 22, 2015
    Report Date
    May 12, 2015
    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
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), EXPLANTED: 2015 (B)(6); PRODUCT TYPE CATHETER PRODUCT ID 8835, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 8590-1, LOT# N174872, IMPLANTED: 2010 (B)(6); PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CATHETER ISSUE WAS AN OCCLUSION AT AN UNKNOWN LOCATION. THE ISSUE WAS IDENTIFIED ON (B)(6) 2015 VIA AN INTRATHECAL PUMP CATHETER CHECK. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT EXPERIENCED LESS THAN 50% THERAPY RELIEF. THERE WAS A LACK OF FLOW FROM THE CATHETER ACCESS PORT (CAP) WHEN ASPIRATED. A CATHETER ISSUE WAS SUSPECTED AND THE CATHETER WAS REPLACED. THE DECISION WAS MADE TO ELECTIVELY REPLACE THE PUMP DURING THE SAME PROCEDURE. THE PATIENT'S STATUS AT THE TIME OF THE EVENT WAS STATED TO BE ALIVE WITH NO INJURY. THE PUMP WAS USED TO DELIVER HYDROMORPHONE. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. 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
    356008 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention