BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4241468 · Received November 10, 2014

    Report

    Report Number
    3004209178-2014-21261
    Event Type
    Injury
    Date Received
    November 10, 2014
    Report Date
    October 24, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3093-28, LOT# VA0FR4A, IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PATIENT RECEIVED ASSISTANCE FROM THEIR DOCTOR OR MANUFACTURER¿S REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. APPOINTMENT DATE WAS NOTED AS (B)(6) 2014. SEE ALSO MANUFACTURER'S REPORT # 3004209178-2014-21256.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN (B)(6) 2014, THE PATIENT FELL ON THE IMPLANTABLE NEUROSTIMULATOR (INS) AND HAD SURGERY IN (B)(6) 2014. THE PHYSICIAN PUT IN A NEW POCKET AND PUT THE LEAD AROUND TO ANCHOR IT MORE. IT WAS REPORTED THAT THE PHYSICIAN MENTIONED THE LEAD ¿MIGHT HAVE MOVED¿. FOLLOW UP HAS BEEN ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED. SEE MANUFACTURER¿S REPORT # 3004209178-2014-21256 FOR THE PATIENT¿S OTHER DEVICE ISSUE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721877 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00029 YR Required Intervention