BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2945623 · Received February 6, 2013

    Report

    Report Number
    3004209178-2013-01351
    Event Type
    Injury
    Date Received
    February 6, 2013
    Report Date
    January 17, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# VA00S9Q, IMPLANTED: (B)(6) 2012. 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 PROBLEMS GETTING HER STIMULATION "JUST RIGHT" AND HAD TO GET UP "EVER 2 HOURS AT NIGHT" TO USE THE RESTROOM. THE PATIENT STATED THAT HER IMPLANT WAS "STILL INFECTED." TROUBLESHOOTING COULD NOT BE DONE BECAUSE THE POCKET SITE WAS "TOO PAINFUL." THE PATIENT HAD NOTIFIED THE HEALTH CARE PROVIDER ABOUT THE INFECTION AND HAD AN APPOINTMENT SCHEDULED FOR (B)(6) 2013. FURTHER INFORMATION HAS BEEN REQUESTED. IF MORE INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT A CULTURE WAS DONE AND THERE WAS NO INFECTION. THE INFECTION LOCATION WAS THE RIGHT SIDE OF THE POCKET AND THE IMPLANT AND LEAD WERE REMOVED. THE PATIENT WAS "FINE AND TAKING FIBER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50641 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention