BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2983618 · Received February 28, 2013

    Report

    Report Number
    3004209178-2013-03187
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    February 11, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3093-28 LOT# V705285, IMPLANTED: 2011 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT HER DEVICE WAS TOTALLY EXPLANTED AND REPLACED. THE PATIENT NOTED THE REASON FOR EXPLANT WAS THAT IT WAS NOT DONE RIGHT AND THE PATIENT NEVER FELT STIMULATION, NO MATTER THE TROUBLESHOOTING. ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND WHEN AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    SUPPLEMENTAL INFORMATION RECEIVED REPORTED BY THE PATIENT'S HEALTH CARE PROFESSIONAL (HCP) THAT THE CAUSE OF THE EVENT WAS THE PATIENT STATED NONFUNCTIONING DEVICE AND THIS WAS REPLACED. IT WAS INDICATED THAT THE ORIGINAL DEVICE WAS PLACED BY ANOTHER DOCTOR. A SURGICAL REVISION WAS NOTED INVOLVING THE DEVICE AND THE LEAD, WHICH TOOK PLACE THREE MONTHS AGO. THE PATIENT DID NOT REQUIRE HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86577 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention