BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 1040266 · Received May 8, 2008

    Report

    Report Number
    3004209178-2008-02459
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 15, 2008
    Report Date
    May 31, 2018
    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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# V088840, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH AN INTERSTIM II DEVICE HAD AN INFECTION AT THE STIMULATOR SITE. AFTER A LEAD REVISION, THE PATIENT WENT TO AN ER AND THE SWELLING DOUBLED IN SIZE WITHIN 1 HOUR OF WAITING. THE HCP CONFIRMED THAT THE PATIENT DID HAVE SWELLING AND CELLULITIS AT THE DEVICE POCKET SITE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL AND CONSUMER REGARDING A PATIENT IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION. IT WAS REPORTED PATIENT HAD AN INFECTION AND WITHIN AN HOUR AFTER IMPLANT SWELLING HAD NEARLY DOUBLED IN SIZE. PATIENT HAD REVISION DUE TO LEADS NOT CONNECTED OR WORKING PROPERLY AND WAS ADMITTED TO THE HOSPITAL. IT WAS LATER MENTIONED THAT PATIENT DID NOT HAVE AN INFECTION AND ONLY HAD SWELLING, BUT HAD CELLULITIS OVERLYING THE POCKET TWO WEEKS AFTER IMPLANT AND HAD A REVISION; HOWEVER, THE PATIENT STATED THEY HAD AN INFECTION IN THEIR HIP 7 DAYS PRIOR TO EXPLANT, AND THEN FURTHER MENTIONED THEY WERE HOSPITALIZED FOR 7 DAYS. PATIENT STATED THEY HAD BEEN HOSPITALIZED 11 TIMES IN DIFFERENT STATES AND THAT THEY COULD NOT STAND UP. NO FURTHER COMPLICATIONS WERE 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R