BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2070146 · Received April 21, 2011

    Report

    Report Number
    3007566237-2011-02964
    Event Type
    Injury
    Date Received
    April 21, 2011
    Date of Event
    August 17, 2010
    Report Date
    April 6, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: THE PUMP PASSED ALL NON-DESTRUCTIVE TESTING IN THE ANALYSIS LAB. THE DEVICE FUNCTIONED NORMALLY. THE CATHETER ALSO HAD ACCEPTABLE TESTING. NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    THE PUMP WAS REPLACED DUE TO ROUTINE REPLACEMENT DUE TO NORMAL BATTERY DEPLETION. THE ORIGINAL CATHETER TIP WAS NO LONGER HIGH ENOUGH DUE TO PT GROWTH. IT WAS REPLACED WITH THE NEW CATHETER POSITIONED TO THE ORIGINAL IMPLANT LOCATION. THE HCP REPORTED THAT THE CATHETER DISLODGED. NO ROTOR STUDY OR DYE STUDY WAS PERFORMED. THE PT WAS HOSPITALIZED ASSOCIATED WITH THE EVENT. THERE WAS NO PT INJURY. THE PUMP WAS USED TO DELIVER LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization| R EXPLANTED:| CATHETER: MODEL 8709, LOT# J11891R20| IMPLANTED: