BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1647025 · Received March 26, 2010

    Report

    Report Number
    3007566237-2010-02464
    Event Type
    Malfunction
    Date Received
    March 26, 2010
    Date of Event
    March 1, 2010
    Report Date
    March 2, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) -(CONSTIPATION).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED INCREASED BASELINE PAIN AND NEVER HAD THERAPEUTIC EFFECT FROM HER IMPLANTED DEVICE. SHE STATED THAT SHE HAD BACK PAIN AND WAS UNABLE TO HAVE A BOWEL MOVEMENT. THE PATIENT STATED THAT SHE WENT TO THE ER WITH HIGH BLOOD PRESSURES OF 190/115. THE PATIENT HAD TAKEN DILAUDID 4MG ORALLY AND A "BLOOD PRESSURE PILL." SHE HAS A "MICRO VALVE PROLAPSE WITH 3 LEAKAGES." THE PATIENT STATED THAT THE ER PHYSICIAN TOLD HER THAT THE MEDICATION IN HER PUMP WAS "NOT WORKING." THE PATIENT WAS REFERRED TO ANOTHER PAIN MANAGEMENT HCP. THE PATIENT WAS DISCHARGED FROM THE ER AND HER BLOOD PRESSURE WAS 166/100. THE PATIENT FELT THAT HER PAIN WAS FROM THE CATHETER AND WAS CONCERNED THAT SOMETHING WAS WRONG WITH THE CATHETER. AN MRI WAS DONE AND WAS "CLEAR"; THE PUMP WAS FUNCTIONING AS IT SHOULD. AN X-RAY SHOWED THAT "HER TUBING IS SET IN PROPERLY." THE PATIENT WANTED INFORMATION ABOUT REMOVING THE PUMP. THE PATIENT LATER STATED THAT SHE EXPERIENCED MORE PAIN AFTER A BOWEL MOVEMENT. THE PATIENT HAD AN APPOINTMENT WITH HER PHYSICIAN TO DISCUSS TREATMENT OPTIONS AND POSSIBLE EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# N097574002| EXPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N110510020| PROGRAMMER: MODEL 8840, LOT# UNKNOWN| IMPLANTED:| ACCESSORY: MODEL 8590-1, LOT# N098678