BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2395105 · Received January 3, 2012

    Report

    Report Number
    3004209178-2012-00016
    Event Type
    Injury
    Date Received
    January 3, 2012
    Report Date
    December 12, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PATIENT PROGRAMMER MODEL 3037, SERIAL # (B)(4), IMPLANTED: NA, EXPLANTED: NA; LEAD MODEL 3093, LOT # V813553, IMPLANTED: (B)(6) 2011, EXPLANTED: UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAD REVISION WAS INITIALLY PERFORMED BECAUSE A LACK OF BENEFIT TO THE PATIENT AND HIGH IMPEDANCE MEASUREMENTS WERE FOUND ON THE ORIGINAL IMPLANT IN (B)(6) 2011. POST-OPERATIVELY, IMPEDANCE MEASUREMENTS OF >4000 OHMS ON SOME OF THE BIPOLAR PAIRS WERE FOUND. AFTER THE HEALTHCARE PROVIDER FOUND THE HIGH IMPEDANCES POST-OPERATIVELY, THE HCP WENT BACK INTO THE OPERATING ROOM AND DID A REPLACEMENT OF THE INS. ALL IMPEDANCES WERE, SUBSEQUENTLY, FOUND TO BE WITHIN A NORMAL RANGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention