BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3203523 · Received July 3, 2013

    Report

    Report Number
    3004209178-2013-11238
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Report Date
    June 7, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT # V177511, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE WEEKS PRIOR TO THE REPORT, THE PATIENT WENT TO THE CHIROPRACTOR AND A ¿ROLLY THING¿ WAS USED ON HIS BACK DUE TO BACK PAIN. THERE WAS REPORTEDLY A ¿BUMP¿ AT ¿THE BOTTOM OF THE TAILBONE, WHERE THE LEAD CONNECTED TO THE IMPLANTABLE NEUROSTIMULATOR (INS).¿ AFTER THE APPOINTMENT, THE PATIENT NOTICED THAT THE ¿BUMP¿ HAD MOVED ¿ABOUT HALF AN INCH.¿ EVER SINCE THEN, THE PATIENT HAD BEEN CONSTIPATED. THE PATIENT HAD NOT HAD ANY FALLS OR TRAUMA NOR HAD THERE BEEN ANY CHANGES MADE TO THE PATIENT¿S MEDICATION. THE REPORTER INDICATED THAT THE PATIENT MET WITH A MANUFACTURER¿S REPRESENTATIVE AND HEALTHCARE PROVIDER (HCP) AND IT WAS STATED THAT THE LEAD WAS ¿FUNCTIONALLY CORRECT¿ AND THE INS HAD ABOUT 1.5 YEARS OF LIFE LEFT. THE PATIENT WAS HOWEVER ¿SURE¿ THAT THE LEAD HAD MIGRATED AND WAS THE CAUSE OF THE CONSTIPATION. IT WAS NOTED THAT THE PATIENT HAD NOT NOTICED ANY RETURN OF SYMPTOMS AND THE DE VICE WAS CONTROLLING HIS URINARY SYMPTOMS WELL. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303801 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1