BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4173573 · Received October 15, 2014

    Report

    Report Number
    3004209178-2014-19722
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    June 19, 2014
    Report Date
    September 24, 2014
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3889-28, LOT# VA0FNS7, IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A WIRE TOUCHED THE PATIENT¿S TAILBONE NERVE DURING IMPLANT. THE PATIENT¿S STIMULATOR WAS PROTRUDING AND CAUSING PAIN. THE PATIENT WAS NOT INSTRUCTED ON HOW TO TURN STIMULATION OFF. THE SYSTEM WAS REPLACED TWO MONTHS LATER. THE NEW STIMULATOR WAS PUT IN A NEW POCKET AND DID NOT PROTRUDE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT STILL HAD CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR HEALTH CARE PROVIDER (HCP) OR MANUFACTURER REPRESENTATIVE. THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2014. THE PATIENT ALSO STILL HAD CONCERNS WITH THEIR DEVICE OR THERAPY BUT HAD NOT SOUGHT FURTHER HELP. THE PATIENT WAS IN THE "30 DAY WINDOW" AND THEY NEEDED HELP AS THEIR HCP NO LONGER TOOK THEIR INSURANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654678 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention