BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3021660 · Received March 26, 2013

    Report

    Report Number
    3004209178-2013-04252
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    July 3, 2012
    Report Date
    January 16, 2020
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: 3889-28, LOT# J0437123V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    DUE TO IMDRF HARMONIZATION, SOME PREVIOUSLY SUBMITTED DEVICE, METHOD, RESULT, AND CONCLUSION CODES RELATED TO THIS EVENT MAY HAVE BEEN UPDATED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE INS HAS BEEN IRRITATING THE PATIENT SINCE IMPLANT DUE TO IT BEING IMPLANTED RIGHT AT HIS BELT LINE. ABOUT ONE WEEK AGO THE PATIENT UNDERWENT SURGICAL INTERVENTION AND THE INS WAS LOWERED. HE HAS A FOLLOW UP APPOINTMENT ON (B)(6) 2013. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THE PATIENT HAD PAIN IN THEIR BACK IN THE AREA OF THE IMPLANT. THEY HAD THE DOCTOR PUT THE DEVICE IN DEEPER BECAUSE THEY FELT THEIR BELT WAS HITTING IT. HOWEVER, IT HAD GOTTEN WORSE AND THE NEXT TIME THEY ASKED THE DOCTOR THE SAME THING AND THEY ¿PUT IN AS FAR AS THEY COULD.¿ NO FURTHER PATIENT COMPLICATIONS ARE ANTICIPATED OR EXPECTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124190 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention