BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2895516 · Received January 3, 2013

    Report

    Report Number
    3007566237-2013-00030
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 3, 2012
    Report Date
    December 6, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTION. ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP MOTOR REVEALED THE COIL SHORTED TO THE CASE. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE PATIENT HAD THEIR PUMP EXPLANTED.

    Description of Event or Problem · 1

    A MOTOR STALL WAS REPORTED, AND THE PUMP WAS REPORTED TO BE OPERATING IN SAFE STATE. PATIENT HOSPITALIZATION AND INTERVENTION WERE NOTED TO BE RELATED TO THIS EVENT, AND A PUMP REPLACEMENT WAS SCHEDULED. NO PATIENT SYMPTOMS OR INJURIES WERE KNOWN TO BE RELATED TO THIS EVENT. THE MEDICATION USED WITHIN THE SYSTEM WAS MORPHINE. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS SUBMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2689 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Hospitalization| R