BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 4101660 · Received September 19, 2014

    Report

    Report Number
    3004209178-2014-17361
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    August 27, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3031A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3093-28, LOT# J0444333V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD NO STIMULATION SENSATION AND A LOSS OF THERAPEUTIC EFFECT. THE PATIENT HAD AN UNRELATED HOSPITAL STAY, WITH CT AND PET SCANS INVOLVED. THE PATIENT¿S MEDICATION WHILE IN THE HOSPITAL MADE THEIR ¿BOWELS OUT OF SORTS.¿ THE PATIENT THEN PLAYED WITH THE STIMULATOR AND MESSED IT UP. STIMULATION DID NOT WORK FOLLOWING THE HOSPITAL STAY. THE PATIENT¿S STIMULATOR WAS CONFIRMED ON, BUT COULD NOT FEEL STIMULATION. INCREASING STIMULATION DID NOT RESOLVE THE ISSUE. THE PATIENT¿S SYMPTOMS HAD RETURNED. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584008 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR