BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3542726 · Received December 30, 2013

    Report

    Report Number
    3004209178-2013-24156
    Event Type
    Injury
    Date Received
    December 30, 2013
    Date of Event
    December 10, 2013
    Report Date
    December 10, 2013
    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
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3093-33, LOT #: V972782, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS REMOVED DUE TO INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THE HEALTHCARE PROVIDER (HCP) HAD NO RECORD OF THE PATIENT HAVING AN INFECTION. THE INTERSTIM SYSTEM WAS REPLACED BECAUSE IT WAS MALFUNCTIONING. THE PATIENT HAD AN APPOINTMENT WITH THE HCP ON (B)(6) 2013 AND INDICATED THE INTERSTIM HAD WORKED INITIALLY, BUT WAS NO LONGER WORKING. IT WAS STATED THE PATIENT HAD BEEN KICKED IN THE BACK BY THEIR GRANDCHILDREN AND HAD BEEN LIFTING HEAVY OBJECTS. COMMUNICATION WITH THE DEVICE WAS NOT POSSIBLE WITH THE PATIENT PROGRAMMER OR CLINICIAN PROGRAMMER. IMPEDANCES MEASUREMENTS WERE TAKEN AND THEY INDICATED THERE WAS A FRACTURE. THE ENTIRE SYSTEM WAS REPLACED ON (B)(6) 2013. WHEN THEY SYSTEM WAS REMOVED IT WAS NOTICED THE LEAD WAS FRACTURED. THE PATIENT WAS RE-IMPLANTED WITH A NEW SYSTEM AND WAS DOING FINE. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679106 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Required Intervention