BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 2870754 · Received December 12, 2012

    Report

    Report Number
    3007566237-2012-02996
    Event Type
    Injury
    Date Received
    December 12, 2012
    Report Date
    November 13, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER HAD BECOME DISCONNECTED. THE REPORTER MENTIONED THAT THROUGHOUT THE YEARS OF CHANGING THE CATHETERS, SOME FLOATING PIECES OF CATHETER REMAINED IN THE PATIENT'S SPINAL AREA. THE PATIENT WAS TOLD BY HIS PHYSICIAN THAT IT WAS BEST TO LEAVE THE CATHETER PIECES DUE TO THE RISK TO REMOVE THEM. THE DEVICE SYSTEM WAS USED TO DELIVER HYDROMORPHONE, BUPIVACAINE AND COMPOUNDED BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R