BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

    MDR report key: 6304118 · Received February 6, 2017

    Report

    Report Number
    3007566237-2017-00575
    Event Type
    Injury
    Date Received
    February 6, 2017
    Date of Event
    January 1, 2010
    Report Date
    February 17, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THEIR RIGHT FOOT WOULD CRAMP AT THE ARCH WHEN THEY WOULD HAVE A BOWEL MOVEMENT IN 2010. AFTERWARD, THEY WOULD HAVE TO STRETCH THE NERVE OUT AND IT WOULD GO AWAY. IT WAS INDICATED THAT THE SYSTEM WAS REMOVED AND REPLACED ON (B)(6) 2010 BECAUSE IT WAS NOT GIVING THE PATIENT THE MOST RELIEF AND THEY HAD A RETURN AND INCREASE IN FREQUENCY. THE HEALTHCARE PROVIDER (HCP) TOLD THE PATIENT THAT THE NEW MODEL WOULD PROVIDE BETTER THERAPEUTIC EFFECT. IT WAS NOTED THAT THE HCP HAD A HARD TIME FINDING THE LEAD DURING THE EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) AND IT WAS REPORTED THAT THE CAUSE OF THE CRAMPING IN THE FOOT AND LACK OF THERAPEUTIC EFFECT WAS NOT DETERMINED. THE HCP REPORTED THAT EVEN WITH THE DEVICE TURNED OFF THE PATIENT WAS STILL EXPERIENCING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85993 STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention