BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3202394 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-00966
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    March 7, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH. PRODUCT TYPE: CATHETER: PRODUCT ID NEU_UNKNOWN _CATH. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    A PROBLEM WAS REPORTED. PATIENT¿S FRIEND/ FAMILY MEMBER REPORTED A CHANGE IN THE THERAPY EFFECT. INCREASE IN BASELINE PAIN, SEVERE PAIN AND PATIENT UNABLE TO SLEEP WERE REPORTED. ALSO REPORTED PATIENT THREATENED TO HARM HIMSELF IF HE DID NOT GET PAIN RELIEF ¿ HE WAS TALKING ABOUT KILLING HIMSELF DUE TO THE PAIN. CALLER INDICATED THE PATIENT WAS NOT GETTING DRUG, BUT NO ALARMS WERE SOUNDING. A CATHETER ISSUE WAS SUSPECTED. THE PATIENT WENT THROUGH WITHDRAWAL. REPORTER INDICATED EVENT OCCURRED FOLLOWING AN MRI SCAN IN DECEMBER 2011. STATED THAT PUMP WORKED PERFECTLY UNTIL MRI AND PATIENT NEVER GOT PAIN RELIEF AFTER THE SCAN. STATED THAT PUMP WAS REPLACED LAST WEEK AND THE NEW PUMP WAS NOT WORKING EITHER. IF ADDITIONAL INFORMATION IS RECEIVED A REPORT WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303038 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention