BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 4202685 · Received October 27, 2014

    Report

    Report Number
    3007566237-2014-03118
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    August 7, 2014
    Report Date
    October 16, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD BLADDER PROBLEMS. THE EVENT WAS ONGOING AND NOTED AS UNLIKELY RELATED TO DEVICE, THERAPY, OR PROCEDURE. THE PATIENT¿S BLADDER PROBLEMS WERE DUE TO THEIR PROGRAMMING. ADDITIONAL INFORMATION REPORTED THE PATIENT ALSO HAD PAIN DURING MICTION AND LOSS OF SOME BLOOD AT END OF MICTION. INTERVENTION INCLUDED REPROGRAMMING AND ADMINISTRATION OF ANTIBIOTICS AND IBUPROFEN 600 MG FOUR TIMES DAILY. THE ETIOLOGY WAS POSSIBLY RELATED TO THE DEVICE OR THERAPY AND NOTED AS DUE TO THE PROGRAMMING. NO OUTCOME WAS PROVIDED. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE WAS TURNED OFF AND THE BLADDER PROBLEMS WERE SOLVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE EVENT WAS RESOLVED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE PATIENT ALSO HAD A BURNING SENSATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683732 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention