BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3910622 · Received July 2, 2014

    Report

    Report Number
    3004209178-2014-12467
    Event Type
    Injury
    Date Received
    July 2, 2014
    Report Date
    June 10, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# V634859, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE PATIENT'S STIMULATION SYSTEM HAD BEEN REPLACED IN (B)(6) BECAUSE THE PHYSICIAN COULDN'T GET A READING ON IT ANYMORE AND THEY SAID THAT IT FAILED. THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) AND LEAD WERE REPLACED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INS (STIMULATOR) BATTERY DEPLETION. CALLER STATES PATIENT WAS PREPARING FOR INS REMOVAL AND REPLACEMENT. CALLER STATES THE INTERSTIM WASN'T WORKING RIGHT IN MARCH. CALLER STATES THEY KEPT INCREASING STIMULATION UP TO 6 VOLTS ON ONE PROGRAM. CALLER STATES THEY ALSO RAISED STIMULATION UP TO 6 VOLTS ON ANOTHER PROGRAM. CALLER STATES PATIENT FELT A JOLT WHILE GETTING OUT OF BED. CALLER STATES THEY DID NOT ATTRIBUTE THE JOLT TO THE STIMULATION AT FIRST. CALLER STATES THE JOLTING STARTED TO BE CONSISTENTLY OCCURRING WHILE PATIENT WAS GETTING OUT OF BED SO PATIENT WENT TO HCP (HEALTHCARE PROVIDER) AND THAT'S WHEN HCP DIAGNOSED A PROBLEM WITH INS BATTERY. IT WAS NOTED THAT THE CALLER TRIED TO LEAVE A MESSAGE FOR THE REPRESENTATIVE. CALLER STATES THEY WOULD LIKE INS RETURNED TO MANUFACTURER FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE ROOT CAUSE OF THE REVISION AND/OR REMOVAL WAS RELATED TO A THERAPY OR DEVICE COMPLAINT. IT WAS NOTED THAT THE HE DEVICE OR LEAD HAD FAILED IN SOME KIND OF WAY AND NEEDED TO BE REPLACED. THERE WAS NO ALLEGATION OF SYSTEM USE ISSUE DURING REVISION. IT WAS NOTED THAT THE PATIENT RECOVERED COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388559 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Required Intervention