BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4123175 · Received September 26, 2014

    Report

    Report Number
    3007566237-2014-02718
    Event Type
    Injury
    Date Received
    September 26, 2014
    Report Date
    September 3, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8703, LOT# J92103160, IMPLANTED: (B)(6) 1993, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    DATE RECEIVED BY MFG: THE PREVIOUSLY REPORTED INFORMATION WAS REPORTED BY THE HCP.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS TAKING ORAL BACLOFEN AND OXYCODONE AT THE TIME OF THE EVENT. THE PATIENT'S PAIN WAS A 3 OUT OF 10 ON (B)(6) 2014. THE ONLY CYST IN THE PATIENT'S FILE WAS IN 1986 (IN SPINAL CORD, UNKNOWN LOCATION), IN WHICH SURGERY WAS PERFORMED. THE REPORTER HAD NOT PERFORMED A DYE STUDY. THE REPORTER HAD NO OTHER INFORMATION AT THE TIME OF THE EVENT; AS THE EVENT WAS NOT REPORTED TO THE HEALTHCARE PROVIDER (HCP). NO OUTCOME WAS REPORTED REGARDING THIS EVENT. ADDITIONAL INFORMATION COULD NOT BE OBTAINED AT THE TIME OF THE REPORT. SHOULD ADDITIONAL BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT GOT A CYST DUE TO OIL BASED DYE, THE CYST CRUSHED ALL THE NERVE ON THE LEFT SIDE OF THE SPINAL COLUMN. NOW PAIN WAS ALL ON THE RIGHT SIDE. THE LAST 6 MONTHS THE PATIENT COULD NOT BEND WITHOUT PAIN, "OTHERWISE SHE WOULD HAVE TO USE A LIDODERM PATCH." THE PUMP SYSTEM WAS DELIVERING BUPIVACAINE AND DILAUDID. (NO OUTCOME WAS REPORTED REGARDING THIS EVENT. IT WAS UNKNOWN WHAT WAS INFUSING AT THE TIME OF THE EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602652 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Other