BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3070530 · Received April 22, 2013

    Report

    Report Number
    3007566237-2013-01373
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    March 25, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN SUSPECTED THE PATIENT MAY HAVE A GRANULOMA. A MAGNETIC RESONANCE IMAGING (MRI) SCAN COULD NOT BE DONE DUE TO THE PATIENT'S SHRAPNEL WOUNDS FROM COMBAT. A SPIRAL COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS DISCUSSED. IT WAS UNKNOWN WHAT MEDICATION THIS DEVICE SYSTEM DELIVERED AS NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    NO FURTHER INFORMATION WAS AVAILABLE AS IT WAS LATER REPORTED THAT THE PHYSICIAN DID NOT RECALL THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171861 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other