BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2797983 · Received October 22, 2012

    Report

    Report Number
    3004209178-2012-09380
    Event Type
    Injury
    Date Received
    October 22, 2012
    Report Date
    September 24, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3889-28 LOT# V221049 IMPLANTED: 2009 (B)(6), EXPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3037 SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN IMPLANTABLE NEUROSTIMULATOR (INS) AND LEADS REPLACED DUE TO "FAILURE." THE REASON FOR INITIAL INS FAILURE WAS UNKNOWN. IT OCCURRED LESS THAN A YEAR AFTER IMPLANT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE DOCTOR COULD NOT GET ¿ALL LEADS IN¿ INITIALLY. NO FURTHER INFORMATION WAS REPORTED.

    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