BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4133314 · Received October 1, 2014

    Report

    Report Number
    3004209178-2014-18119
    Event Type
    Injury
    Date Received
    October 1, 2014
    Report Date
    September 9, 2014
    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
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 309328, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD THEIR SYSTEM REMOVED. THE CAUSE OF THE SHOCKING/PAIN WAS NOT IDENTIFIED. THE PATIENT WAS TO BE RE-IMPLANTED, BUT A PROCEDURE DATE HAD NOT YET BEEN SET.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED ¿GOOD¿ THERAPY UNTIL THEY FELL ON ROCKS ON A BEACH. THE PATIENT SAW THE NURSE AT THE CLINIC AND HIGH IMPEDANCES WERE MEASURED. STIMULATION WAS REPROGRAMMED AROUND THE OPEN CIRCUITS. THE PATIENT¿S LAST SETTING WAS NOTED TO BE C+, 0-, AND 1-. DURING THE WEEK OF THE REPORT, THE PATIENT RETURNED TO THE CLINIC DUE TO PAIN AND SHOCKING SENSATIONS. THE PATIENT WOULD EXPERIENCE SHOCKING AFTER A HALF HOUR OF NORMAL STIMULATION. IT WAS ALSO STATED THAT IF IT WAS ON, IT WAS NOT WORKING AFTER 10-15 MINUTES, AND THEN THE PATIENT WOULD GET AN ¿ELECTRIC SHOCK PAIN.¿ THE PAIN WAS AT THE DEVICE POCKET IN THE BUTTOCKS AND IT FELT LIKE THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS BEING ¿PUSHED OUT/FORCED OUT THEIR BOTTOM¿ IT WAS ALSO DESCRIBED AS ¿A PRESSURE-TYPE PAIN¿ AND ¿INTOLERABLE¿ PAIN. THE INS WAS SWITCHED OFF DUE TO THIS. THE PATIENT WAS SCHEDULED TO HAVE SURGERY TO REPLACE THE LEAD A ND EXAMINE THE INS ¿WITH VIEW TO MOBILIZING TO A DIFFERENT PLACE.¿ NO OUTCOME WAS PROVIDED WITH THIS EVENT. A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610835 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention