BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3021394 · Received March 26, 2013

    Report

    Report Number
    3004209178-2013-04237
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 24, 2013
    Report Date
    July 1, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE PUMP REVEALED A PUMP MOTOR GEAR TRAIN ANOMALY WHICH CONSISTED OF CORROSION, WEAR, AND/OR LUBRICATION.

    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 A CONFIRMED MOTOR STALL OCCURRED ON (B)(6) 2013. THE PUMP WAS LAST UPDATED ON (B)(6) 2013. THE PATIENT PRESENTED TO THE CLINIC WITH ACUTE WITHDRAWAL, REBOUND SPASTICITY, TREMOR, PRURITUS, AND TACHYCARDIA. THE CAUSE OF THE STALL WAS UNKNOWN. THE PATIENT WAS TO BE POSSIBLY ADMITTED. ELECTIVE REPLACEMENT INDICATOR (ERI) WAS NOTED TO BE 18 MONTHS. THE DRUG IN THE PUMP WAS BELIEVED TO BE GABLOFEN, ALTHOUGH THE CALLER WAS UNSURE, AS THE DOCUMENTATION DID NOT DELINEATE BETWEEN GABLOFEN AND LIORESAL (BACLOFEN). IT WAS ADDITIONALLY REPORTED THAT THE PUMP WAS EXPLANTED AND THE MOTOR STALL RECOVERED AFTER EXPLANT. THE PATIENT WAS TO BE DISCHARGED HOME WITH THE SAME DOSAGE AS BEFORE.

    Description of Event or Problem · 1

    THE PATIENT WAS LATER REPORTED AS DOING "FINE."

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT BASED ON LOT INFORMATION THE DRUG USED IN THE DEVICE SYSTEM WAS GABLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122942 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Hospitalization| R