BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2765624 · Received September 28, 2012

    Report

    Report Number
    3004209178-2012-08689
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    August 27, 2012
    Report Date
    August 31, 2012
    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
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-33, LOT# V963207, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT LOST THERAPEUTIC EFFECT. PATIENT LOST BLADDER CONTROL AND URINATES WHEN STANDS UP. SYMPTOMS STARTED AFTER A HIP REPLACEMENT SURGERY ON (B)(6) 2012. DEVICE WAS TURNED OFF BEFORE THE PROCEDURE AND TURNED ON THE DAY AFTER PROCEDURE. PATIENT HAD CATHETER DURING SURGERY. STIMULATION WAS FELT DURING THE MORNING, BUT NOT AT THE MOMENT OF THIS REPORT. SYMPTOMS ARE IN THE PERINEUM. PATIENT HAD PAIN IN THE LOWER STOMACH AFTER TURNING STIMULATION ON AND BEFORE THE SURGERY. PATIENT HAD PAIN EVEN WHEN STIMULATION IS OFF. IMPLANTABLE NEUROSTIMULATOR (INS) WAS ON LEFT SIDE OF THE BODY AND PATIENT HAD X-RAY ON RIGHT HIP ON (B)(6) 2012. MEDTRONIC REPRESENTATIVE HELPED PATIENT ADJUSTING STIMULATION PARAMETERS WITH PATIENT PROGRAMMER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR