BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 5736966 · Received June 20, 2016

    Report

    Report Number
    3004209178-2016-12563
    Event Type
    Injury
    Date Received
    June 20, 2016
    Date of Event
    January 1, 2012
    Report Date
    July 13, 2016
    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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V120752, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: SEX, DATE OF BIRTH. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THE PATIENT HAD THE IMPLANTABLE NEUROSTIMULATOR (INS) AND LEAD REMOVED BUT A PORTION OF THE LEAD REMAINED IMPLANTED. THE PATIENT HAD CLAIMED THE SYSTEM WAS REMOVED BECAUSE IT WAS NOT WORKING AND THEY HAD REQUESTED THE EXPLANT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A PATIENT. IT WAS REPORTED THE IMPLANT HAD NOT WORKED FOR THEM AND WHEN THEY HAD GONE FOR A MRI THEY HAD BEEN TURNED DOWN DUE TO THE LEAD FRAGMENT THAT WAS NOT EXPLANTED. THE PATIENT DID NOT KNOWN THE EXACT DATE THEY HAD BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390876 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention