BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2594798 · Received May 31, 2012

    Report

    Report Number
    3004209178-2012-03882
    Event Type
    Injury
    Date Received
    May 31, 2012
    Report Date
    May 4, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    LEAD: MODEL 3889-28, LOT# V813487, IMPLANTED: 2011 (B)(6), EXPLANTED: NA, PROGRAMMER: MODEL 3037, LOT#, SERIAL# (B)(4). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SEVERAL FALLS SINCE THE IMPLANTATION OF HER NEUROSTIMULATOR (INS). IT WAS ALSO NOTED THAT SHE H AD A BLOOD CLOT IN HER LEG AND EXPERIENCED SEVERE PAIN AT THE INS SITE. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE EVENT WAS NOT RELATED TO THE IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT HAS HAD "BACK ISSUES" FOR MANY YEARS AND HAD AN ACUTE BACK EVENT AFTER A FALL. THERE WERE NO ABNORMAL IMPEDANCE MEASUREMENTS AND AN X-RAY SHOWED NO LEAD MIGRATION. THE PATIENT HAD NO HOSPITALIZATION OR INJURY AS A RESULT OF THE EVENT.

    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