BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2752732 · Received September 20, 2012

    Report

    Report Number
    3004209178-2012-08328
    Event Type
    Injury
    Date Received
    September 20, 2012
    Report Date
    August 22, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37092, LOT# 277370001, IMPLANTED: 2011 (B)(6), PRODUCT TYPE ACCESSORY, PRODUCT ID 3093-28, LOT# V800432, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP REPORTED THE PATIENT DID HAVE CONCERNS WITH THEIR DEVICE OR THERAPY. THE PATIENT HAS HAD CONTINUED DECLINE IN THEIR HEALTH AND WILL HAVE THE DEVICE REMOVED BECAUSE THEY NEED AN MRI. IT WAS NOTED THE PATIENT RECEIVED ASSISTANCE FROM THEIR DOCTOR OR REPRESENTATIVE AND THEIR CONCERNS RESOLVED. IT WAS NOTED THE PATIENT HAD APPOINTMENTS (B)(6) 2012. IT WAS ALSO NOTED THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WERE WORKING WITH THEIR DOCTOR OR REPRESENTATIVE. IT WAS UNCLEAR WHETHER THAT PATIENT'S CONCERNS WERE RESOLVED OR IF THEY WERE STILL PRESENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR 'WAS COMING OUT OF THE POCKET.' PATIENT JUST HAD A REVISION IN WHICH A NEW POCKET WAS MADE AND THAT SHE WAS STILL GROGGY. PATIENT'S DOCTOR ORDERED A VERY SPECIFIC TYPE OF MAGNETIC RESONANCE IMAGING BECAUSE PATIENT HAD BLADDER PROBLEM, PELVIC AND BACK PAIN ALONG WITH MIGRAINES. 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 MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention