BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3840280 · Received May 30, 2014

    Report

    Report Number
    3004209178-2014-09861
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    March 20, 2014
    Report Date
    May 8, 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
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-28, LOT # V179757, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE (NEUROSTIMULATOR) ((B)(4)) REVEALED NO ANOMALY FOUND WITH THE INS HYBRID. NO EVIDENCE OF AN INTERNAL MECHANISM FOR PREMATURE DEPLETION WAS FOUND DURING INTERNAL BATTERY DESTRUCTIVE ANALYSIS. NO PROBLEMS WERE FOUND WITH THE BATTERY.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD HOSPITAL SAME-DAY SURGERY FOR A PROCEDURE RELATED TO REPLACEMENT OF THEIR IMPLANTABLE NEUROSTIMULATOR (INS) ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT¿S UROLOGIST DOCUMENTED THAT THE REASON FOR THE EXPLANT WAS RELATED TO DEVICE BATTERY FAILURE. IT WAS NOTED THAT THE DOCUMENTATION OF THE PROCEDURE REVEALED THAT THE PATIENT WAS HAVING URINARY FREQUENCY, URGENCY, AND URGE INCONTINENCE THAT WAS RELATED TO THE BATTERY FAILURE OF THE DEVICE. IT WAS REPORTED THAT THE PATIENT WAS PLACED UNDER MAC (MONITORED ANESTHESIA CARE) ANESTHESIA WITH A LOCAL ANESTHETIC, THE LEAD WIRES WERE CHECKED, AND THEY APPEARED TO BE IN GOOD CONDITION. IT WAS NOTED THAT THE OLD INS WAS REMOVED AND REPLACED WITH A NEW INS. IT WAS REPORTED THAT THE DEVICE WAS NOT TURNED ON AFTER THE PROCEDURE, WITH THE UROLOGIST DOCUMENTING THAT A MANUFACTURER REPRESENTATIVE WOULD CONTACT THE PATIENT IN A FEW DAYS TO SET UP AN APPOINTMENT TO TURN ON THE DEVICE AND GIVE INSTRUCTIONS. IT WAS NOTED THAT THE PATIENT RECEIVED POST-OPERATIVE ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318299 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Required Intervention