BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4192547 · Received October 22, 2014

    Report

    Report Number
    3004209178-2014-20157
    Event Type
    Injury
    Date Received
    October 22, 2014
    Report Date
    September 26, 2014
    Manufacturer
    MEDTRONIC 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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. PRODUCT ID: 8578, SERIAL# (B)(4), IM PLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDERDOSE SYMPTOMS AND WITHDRAWAL SYMPTOMS FOLLOWING A PUMP REPLACEMENT. A POCKET EXPLORATION WAS PLANNED. AS OF (B)(6) 2014, THE CATHETER HAD BEEN REVISED WHERE A KINK WAS SUSPECTED. THERAPY WAS ¿RESEND WITHIN NORMAL LIMITS¿. THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL 200MCG/ML. SPECIFIC PATIENT SYMPTOMS, CAUSE OF THE EVENT, AND FINAL PATIENT OUTCOME WERE NOT REPORTED. FURTHER FOLLOW-UP WAS CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAUSE OF THE ISSUE WAS UNKNOWN. THE PATIENT WAS GIVEN ORAL BACLOFEN, INTRAVENOUS VALIUM, AND ADMITTED FOR OBSERVATION, TO MITIGATE OR RESOLVE THE SYMPTOMS. THE ISSUE WAS NOTED AS RESOLVED AND THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671924 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00020 YR Hospitalization| R