BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2864139 · Received December 10, 2012

    Report

    Report Number
    3007566237-2012-02954
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 8, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1579-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE CATHETER; PRODUCT ID 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE CATHETER. (B)(4). FINAL ANALYSIS OF THE PUMP FOUND A PUMP MOTOR FEED THRU ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP WAS REPLACED FOLLOWING INTERMITTENT MOTOR STALLS. IT WAS INITIALLY REPORTED THAT THERE WAS A MOTOR STALL THAT RECOVERED AFTER MORE THAN TWO HOURS, AND MULTIPLE MOTOR STALLS SINCE (B)(6) 2012. THE MOTOR STALLS, ALL WITH RECOVERY, OCCURRED BETWEEN (B)(6) 2012. THE PATIENT DID REQUIRE HOSPITALIZATION AND EXPERIENCED SYMPTOMS OF INCREASED SPASTICITY AND "ITCHING." IT WAS ALSO NOTED THAT THE PATIENT NEEDED TO TAKE ORAL BACLOFEN. THE PUMP WAS REPLACED ON (B)(6) 2012. THE PATIENT OUTCOME WAS REPORTED AS RECOVERED WITH SEQUEL. THE MEDICATION IN THE PUMP WAS COMPOUNDED BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00022 YR Hospitalization| R