BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2885803 · Received December 26, 2012

    Report

    Report Number
    3004209178-2012-12225
    Event Type
    Injury
    Date Received
    December 26, 2012
    Report Date
    December 5, 2012
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V940070, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S SYSTEM WAS REMOVED DUE TO AN INFECTION. THE DATE OF EXPLANT WAS UNKNOWN. THE PATIENT RECEIVED A NEW SYSTEM ON (B)(6) 2012. NO FURTHER INFORMATION WAS PROVIDED. IF MORE INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention