BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2456092 · Received February 16, 2012

    Report

    Report Number
    3004209178-2012-01017
    Event Type
    Injury
    Date Received
    February 16, 2012
    Report Date
    January 19, 2012
    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
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD: MODEL 3889-33, LOT# V221335, IMPLANTED: 2009 (B)(6), EXPLANTED: 2011 (B)(6). LEAD: MODEL 3889-28, LOT# V665624, IMPLANTED: 2011 (B)(6), EXPLANTED: UNK. PROGRAMMER: MODEL 3037, SERIAL# (B)(4). LEAD: MODEL 3037, SERIAL# (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD APPOINTMENTS IN 2010 AND 2011 WITH HER DOCTOR. SHE STILL HAD CONCERNS REGARDING HER DEVICE BUT WAS WORKING WITH HER DOCTOR OR COMPANY REPRESENTATIVE.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED SEVERE TAILBONE PAIN WHILE SITTING. THE INS WAS REPLACED AND LEADS WERE "RE-DONE" BUT IT DID NOT HELP. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    THE HEALTH CARE PROVIDER (HCP) CONFIRMED THAT THE PATIENT EXPERIENCED PAIN AT THE LEAD INSERTION SITE AND PAIN OF THE COCCYX. THE PATIENT WAS VERY SLIM AND THE LEAD WAS UNCOMFORTABLE TO HER WHEN SITTING IN A CHAIR ETC. THE LEAD AND INS WERE REPLACED. HER INCONTINENCE IMPROVED AND THE PAIN OF INSERTION SITE AND COCCYX IMPROVED 10%. THE PATIENT OUTCOME WAS NOTED AS NON-SERIOUS INJURY. THE HCP FELT THE PRIMARY PROBLEM WAS HER LACK OF SUBCUTANEOUS TISSUE AND DIFFICULTY PLACING LEAD DEEP ENOUGH.

    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