BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2599637 · Received June 5, 2012

    Report

    Report Number
    3004209178-2012-04032
    Event Type
    Injury
    Date Received
    June 5, 2012
    Report Date
    June 4, 2012
    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
    MA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT# V842735, IMPLANTED: 2011 (B)(6), EXPLANTED: NA, PRODUCT TYPE: LEAD, PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT WAS ABLE TO FEEL STIMULATION ON PROGRAM 4 AT 3.1 V AND THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS CONFIRMED TO BE ON. IT WAS NOTED THAT THE PATIENT HAD LEAKED URINE THE DAY BEFORE AND HAD TO USE CATHETERS. IT WAS ALSO REPORTED THAT THE INS "FLOPS AROUND" IN THE POCKET. THE PATIENT HAD A PREVIOUS MRI AND HAD TO THE HAVE THE DEVICE TAKEN OUT. IT WAS ALSO NOTED THAT THE PATIENT RECENTLY HAD NEUROSTIMULATOR TRIAL FOR BACK PAIN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE HORIZONTAL PLACEMENT OF THE INS WAS POOR AND WAS ASSOCIATED WITH TENDERNESS. IT WAS NOTED THE INS WAS FLIPPING. AN INS REPLACEMENT WAS SCHEDULED FOR (B)(6)-2012.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS LOOSE IN THE POCKET AND CLOSER TO THE PATIENT'S SPINE THAN IT WAS BEFORE, RESULTING IN PAIN IN THE LEFT BACK FOR THE PAST FEW WEEKS. THE PATIENT WORE A BACK BRACE FOR UNRELATED BACK PROBLEMS. THE INS WAS TURNED OFF. PATIENT OUTCOME WAS NOT PROVIDED.

    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