BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5311806 · Received December 18, 2015

    Report

    Report Number
    3004209178-2015-25307
    Event Type
    Injury
    Date Received
    December 18, 2015
    Date of Event
    November 24, 2015
    Report Date
    November 25, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER VIA A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT RECEIVING INTRATHECAL BACLOFEN (TYPE, LOT NUMBER, CONCENTRATION, AND DOSE UNKNOWN) VIA AN IMPLANTED PUMP. THE PUMP'S INDICATION FOR USE (IFU) WAS LISTED AS INTRACTABLE SPASTICITY. ON (B)(6) 2015, THE PATIENT FELT DROWSY, WAS DIZZY, MUSCLES LIKE JELLO�WEAKNESS, LETHARGY, AND NOW HAD NAUSEA AND VOMITING. THE CHANGE IN THERAPY/SYMPTOMS WAS SUDDEN. DRUG INFORMATION, OTHER MEDICATIONS THE PATIENT WAS TAKING AT THE TIME OF THE EVENT, MEDICAL HISTORY, TROUBLESHOOTING PERFORMED WITH RESULTS, ACTIONS/INTERVENTIONS TAKEN, AND PATIENT OUTCOME WERE NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. A HEALTHCARE PROFESSIONAL (HCP) LATER REPORTED ADDITIONAL INFORMATION. STARTING (B)(6) 2015 THE PATIENT'S PUMP WAS USED TO DELIVER GABLOFEN (LOT 2163-112; 2000 MCG/ML AT 300 MCG/DAY). THE PATIENT'S CONCOMITANT MEDICATIONS INCLUDED AVONEX, LYRICA, ATENOL, AND HCTZ. AND THE PATIENT铠MEDICAL HISTORY INCLUDED MULTIPLE SCLEROSIS. THE HCP HAD NO INFORMATION ABOUT THE EVENT EXCEPT A NOTE IN THEIR MEDICAL RECORDS SYSTEM FROM (B)(6) 2015 WHERE THE PATIENT HAD AN EMERGENCY ROOM VISIT DUE TO DECREASED ENERGY AND WEAKNESS. THE PUMP RESERVOIR WAS ACCESSED AND REFILLED AND THE PATIENT WAS ADMITTED OVERNIGHT. THE HCP WAS NOT NOTIFIED OR INVOLVED IN THE EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER. PER THE CLINIC CLINIC NOTE DATED (B)(6) 2015 THE PATIENT HAD CALLED THE PHYSICIAN OFFICE AND REPORTED THEY WENT TO THE EMERGENCY ROOM (ER) ON (B)(6) 2015 DUE TO BEING WEAK, HAVING NO ENERGY AND CAN BARELY WALK. THE PATIENT ALSO FELT SHE HAD A SINUS INFECTION. AT THE ER THE PUMP WAS EMPTIED AND REFILLED. A CT SCAN WAS DONE. MAGNETIC RESONANCE IMAGING (MRI) AND INTRAVENOUS (IV) STEROIDS WERE PLANNED BUT THE PATIENT DECIDED TO GO HOME. THE PATIENT WAS GIVEN A PRESCRIPTION FOR ZITHROMYCIN 250 MG TAB; TAKE TWO ORALLY ON DAY 1; THEN ONE TAB ORALLY DAILY FOR ONE WEEK. THE PATIENT HAD BEEN THERE LAST ON (B)(6) AND SAID SHE HAS NEVER HAD THESE SYMPTOMS BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837468 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Hospitalization