BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3140971 · Received June 3, 2013

    Report

    Report Number
    6000032-2013-00145
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    September 19, 2017
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3080, LOT# L65610, IMPLANTED: (B)(6) 2000, EXPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2000, EXPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. (B)(4).

    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 HAD BROKEN LEAD WIRES 10 TO 15 YEARS AGO ON HER FIRST IMPLANT, ALTHOUGH NOT SURE EXACTLY WHEN. IT WAS NOTED THAT AFTER THE DOCTOR HAD GONE IN TO CHANGE THE DEVICE, IT WAS DISCOVERED THAT THE LEADS WERE BROKEN. THE DOCTOR CLOSED UP THE INCISION AND HAD THE PATIENT COME BACK THREE WEEKS LATER TO HAVE THE LEADS REPLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    THE PATIENT CALLED AND REPORTED THAT WHEN THEIR INS WAS REPLACED A FEW YEARS AGO FOR NORMAL BATTERY DEPLETION THEY NOTICED THE LEAD WAS FRACTURED AND SO THE LEAD WAS REPLACED AS WELL. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT. THE PATIENT THOUGHT THAT THE ISSUE OCCURRED 7-8 YEARS PRIOR TO THE CALL. THERE WERE NO FURTHER COMPLICATION REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245035 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT SOFAMOR DANEK PUERTO RICO MFG 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention