BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3041470 · Received April 8, 2013

    Report

    Report Number
    3004209178-2013-04887
    Event Type
    Injury
    Date Received
    April 8, 2013
    Report Date
    March 19, 2013
    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
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID 3093-28. PRODUCT TYPE: LEAD: PRODUCT ID 3031A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3093-28, LOT# J0322075V, IMPLANTED: (B)(6) 2003. PRODUCT TYPE: LEAD: PRODUCT ID 3093-28, LOT# J0228129V, IMPLANTED: (B)(6) 2002. PRODUCT TYPE: LEAD: PRODUCT ID 3031A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3093-28. 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

    NO DEVICE ANALYSIS WAS PERFORMED; THE DEVICES MET RISK BASED CRITERIA.

    Additional Manufacturer Narrative · 1

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

    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 THE PATIENT WAS SCHEDULED TO HAVE THEIR DEVICES AND LEADS REMOVED THE DAY OF REPORT BECAUSE THEY NEEDED AN MRI. IT WAS ALSO REPORTED THE PATIENT'S DEVICE DISPLAYED AN END OF SERVICE OR END OF LIFE MESSAGE. IT WAS REPORTED, ACCORDING TO THE PATIENT, THEIR BATTERIES HAD REACHED END OF SERVICE. IT WAS UNKNOWN IF THE BATTERY DEPLETION WAS EXPECTED OR NOT. LATER THAT DAY, IT WAS REPORTED THE PATIENT WAS SCHEDULED FOR REMOVAL OF THEIR DEVICE. IT WAS ALSO REPORTED THE PATIENT'S LEFT DEVICE AND ONE OF THEIR LEADS WAS EXPLANTED. NO PATIENT DEATH WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143816 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention