BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3852110 · Received June 5, 2014

    Report

    Report Number
    3004209178-2014-10220
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    November 21, 2013
    Report Date
    May 14, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 3889-28, LOT # VA09B8S, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THEDIAGNOSTICS INCLUDED EXAMINATION ON 2013-(B)(6). IT WAS NOTED THAT THE EVENT WAS RELATED TO THE IMPLANTABLE NEUROSTIMULATOR (INS) AND NOT RELATED TO THE PROCEDURE. IT WAS NOTED THAT THE ENTIRE SYSTEM WAS EXPLANTED AND NOT REPLACED ON 2013-(B)(6). IT WAS NOTED THAT THE PATIENT WAS GIVEN ANTIBIOTICS ON 2013-(B)(6). IT WAS NOTED THAT THE EVENT RESOLVED WITH SEQUELAE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE EVENT WAS NOT RELATED TO THE INS AND WAS RELATED TO THE PROCEDURE. IT WAS NOTED THAT THE DEVICE WAS REMOVED DUE TO THE INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE STIMULATOR WAS INFECTED. THE PATIENT PRESENTED WITH FEVER, LOCAL PAIN, ERYTHEMA, INDURATION AROUND THE RIGHT GLUTEAL INCISION WHERE THE IMPLANT HAD BEEN PLACED. THE PATIENT DID NOT RESPONSE TO PARENTERAL ANTIBIOTICS. THE EVENT WAS NOTED AS RESOLVED WITH SEQUELAE. ADDITIONAL INFORMATION REPORTED THE DEVICE WAS REMOVED DUE TO INFECTION. ADDITIONAL INFORMATION REPORTED THE INFECTION CLEARED AND THE PATIENT WAS NO LONGER USING A STIMULATOR DEVICE SINCE THE SYSTEM WAS REMOVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT ACTION WAS TAKEN ON (B)(6) 2013. THE EVENT WAS REPORTED AS RESOLVED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329839 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Hospitalization| R