BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4024649 · Received August 20, 2014

    Report

    Report Number
    3004209178-2014-15611
    Event Type
    Injury
    Date Received
    August 20, 2014
    Report Date
    July 29, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# V933650, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT FELL WITH AN OPEN WOUND AT IMPLANT SITE. AFTER THE FALL, AN INFECTION DEVELOPED AT THE WOUND SITE. AS A RESULT OF THE INFECTION, THE PATIENT HAD TO HAVE THE DEVICE AND THE LEADS EXPLANTED. THE EXPLANT WAS DONE ON (B)(6) 2014. THE HEALTH CARE PROVIDER (HCP) INDICATED THAT THE INJURY WAS NOT RELATED TO THE DEVICE, THERAPY, OR IMPLANT PROCEDURE. THE PATIENT SYMPTOM WAS A 1MM OPENING AT THE IMPLANT SITE. THE ISSUE WAS RESOLVED WITH SEQUELA, WITH THE SEQUELA BEING THAT THE PATIENT REQUIRED SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN INFECTION AT OPEN WOUND THAT DEVELOPED OVER IMPLANT SITE DUE TO FALL. THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE. THE DEVICE WAS EXPLANTED AND THE PATIENT WAS GIVEN ANTIBIOTICS INCLUDING KEFLEX AND BACTRIM. LAB WORK WAS DONE AND THE CULTURES WERE NEGATIVE. THE FALL WAS NOT RELATED TO THE DEVICE OR THERAPY OR IMPLANT PROCEDURE. SYMPTOMS INCLUDE REDNESS AND PUS DRAINAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502972 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00089 YR Required Intervention