BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4609120 · Received March 17, 2015

    Report

    Report Number
    3004209178-2015-04830
    Event Type
    Injury
    Date Received
    March 17, 2015
    Report Date
    February 25, 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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8590-1, LOT # N143104, IMPLANTED: (B)(6) 2008, PRODUCT TYPE ACCESSORY; PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THEIR PREVIOUS PUMP FAILED IN 2014 AND OVERDOSED THE PATIENT. THE ISSUE WAS NOTED AS HAVING BEEN DUE TO A BATTERY FAILURE IN 2014 AS PER THE PATIENT. BEFORE THE BATTERY HAD FAILED, IT WAS NOTED THAT A PHYSICIAN HAD INCREASED THE DRUG CONCENTRATION. THE PATIENT HAD NEVER BEEN ABLE TO HEAR THE PUMP ALARM. WHEN THE PHYSICIAN CHECKED THE PREVIOUS PUMP, IT WAS NOTED THAT THE PUMP HAD ALARMED. THE PATIENT WAS TOLD BY THE MEDICAL COMMUNITY THAT ¿THEY MAY BE IN THE 2% OF HIGH DELIVERY ¿ VOLUME OR CON CENTRATION.¿ THE PUMP WAS USED TO DELIVER BACLOFEN. NO PATIENT OUTCOME REPORTED. FURTHER FOLLOW-UP WAS BEING CONDUCTED TO OBTAIN INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181645 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Other