BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1181194 · Received September 30, 2008

    Report

    Report Number
    2182207-2008-06216
    Event Type
    Injury
    Date Received
    September 30, 2008
    Date of Event
    January 1, 2006
    Report Date
    September 3, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER.

    Description of Event or Problem · 1

    THE PATIENT HAD NOT BEEN HAVING SYMPTOM RELIEF SINCE THE DEVICE WAS IMPLANTED. HE STATED THAT AFTER DOSING AND CONCENTRATION CHANGES WITH NO RELIEF, THE HEALTH CARE PROFESSIONAL (HCP) DETERMINED THAT THE PUMP WAS DAMAGED AT THE FIRST REFILL. HE STATED THAT THE PUMP AND CATHETER WOULD BE REPLACED. HE WAS EXPERIENCING SWEATING AND WAS WONDERING IF IT WAS BECAUSE OF WITHDRAWAL, BECAUSE THE HCP HAD TURNED THE PUMP DOWN TO THE LOWEST DOSE. HE ALSO STATED THAT HE HAD BEEN DIAGNOSED WITH BRONCHITIS AND WAS ON ANTIBIOTICS. THE PATIENT WAS ENCOURAGED TO CONTACT HIS HCP. THE HCP REPORTED THAT PATIENT HAD SYMPTOMS OF WITHDRAWAL AND NIGHT SWEATS. AN INTRATHECAL DYE STUDY WAS DONE AND SHOWED A PROBABLE HOLE IN THE CATHETER. A SURGICAL REVISION OF THE CATHETER WAS DONE IN 2008. THE PUMP WAS USED TO DELIVER MORPHINE (25MG/ML); THE PREVIOUS RATE WAS 5.5 MG/DAY, THE NEW RATE WAS 3.0 MG/DAY. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    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 Required Intervention EXPLANTED| CATHETER MODEL 8709| PROGRAMMER MODEL 8840