BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3092819 · Received May 3, 2013

    Report

    Report Number
    3004209178-2013-07305
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 17, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 309510, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: EXTENSION: PRODUCT ID 3889-28, LOT# V006090, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD: PRODUCT ID 3889-28, LOT# UNKNOWN, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD: PRODUCT ID 3031A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 309510, SERIAL# UNKNOWN, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: EXTENSION. (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

    (B)(4). ANALYSIS OF THE EXTENSION, SERIAL #(B)(4), FOUND NO ANOMALY. ANALYSIS OF THE DEVICE, SERIAL #(B)(4), FOUND NO SIGNIFICANT ANOMALY AND IT WAS FUNCTIONALLY OKAY. ANALYSIS OF THE LEAD, LOT #V006090, AND UNKNOWN LEAD FOUND NO SIGNIFICANT ANOMALY. THE LEAD BODIES WERE CUT THROUGH AND SEGMENTED. ANALYSIS OF THE UNKNOWN EXTENSION FOUND NO SIGNIFICANT ANOMALY. THE EXTENSION BODY WAS CUT THROUGH AND SEGMENTED.

    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 THE PATIENT'S SYSTEM WAS REMOVED BECAUSE THE PATIENT NEEDED A FULL BODY MRI SCAN. THE LEADS WERE COMPLETELY REMOVED, BUT FRACTURED DURING REMOVAL. IT WAS NOTED THAT IT WAS "NORMAL ERI". ADDITIONAL INFORMATION RECEIVED INDICATED THAT BATTERY DEPLETION WAS NORMAL. THERE WAS NO PATIENT INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194019 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention