BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3790081 · Received May 5, 2014

    Report

    Report Number
    3004209178-2014-08494
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    March 20, 2014
    Report Date
    April 9, 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
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT # VA0BFU0, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A SUDDEN ONSET OF SHARP STABBING PAIN OVER THEIR BATTERY SITE. THE PATIENT WAS UNABLE TO TOLERATE INTERROGATION DUE TO PAIN EVEN WHEN THE DEVICE WAS OFF. THE PATIENT WAS TO HAVE A REVISION IN (B)(6). INTERVENTION INVOLVED SUSPENDING THERAPY AND ATTEMPTING TO INTERROGATE THE DEVICE. X-RAY WAS DONE AND NOTED THE DEVICE HAD FLIPPED. THE EVENT WAS NOTED AS ONGOING AND POSSIBLY RELATED TO THE DEVICE, THERAPY, AND IMPLANT PROCEDURE. ADDITIONAL INFORMATION REPORTED THE EVENT WAS RESOLVED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MEDICATION ADJUSTMENTS ON 2014-(B)(6) INCLUDED DILAUDID 2 MG PO, BENADRYL 50 MG PO, AND VALIUM 5 MG PO. ADDITIONAL INFORMATION RECEIVED REPORTED THAT INTERVENTION INCLUDED SURGICAL REVISION. IT WAS NOTED THAT SPECIFICALLY CHANGE SITE OF THE BATTERY ON 2014-(B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268542 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR Required Intervention