BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3093181 · Received May 4, 2013

    Report

    Report Number
    3004209178-2013-07316
    Event Type
    Injury
    Date Received
    May 4, 2013
    Report Date
    April 19, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P80025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V744240, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD: PRODUCT ID NEU_UN KNOWN_PROG, SERIAL# UNKNOWN. PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE IMPLANTABLE NEUROSTIMULATOR WAS "PULLED OUT OF" ITS POCKET WHEN THE PATIENT BENT OVER WHILE ON (B)(6) VACATION. THE PATIENT HAD A REVISION THE DAY PRIOR TO THE DATE OF THIS REPORT. IT WAS NOTED THE PATIENT WAS TAKING PAIN MEDICATION. NO PATIENT SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD FELT "REALLY UNCOMFORTABLE."

    Description of Event or Problem · 1

    FOLLOW-UP WITH THE PATIENT¿S HEALTHCARE PROVIDER INDICATED THAT THE CAUSE OF THE EVENT WAS ¿POSSIBLE CAPSULE CONTRACTION¿ LEADING TO PULLING ON THE LEAD. AN X-RAY TAKEN IN (B)(6) SHOWED "LEAD ON STRETCH WITHOUT MUCH LAXITY". THE OLD INCISION WAS OPENED AND A NEW POCKET WAS CREATED FOR THE SAME IMPLANT. THAT IMPLANT WAS ORIENTED INTO POSITION ON (B)(6) 2013 TO MINIMIZE PULL ON IMPLANT. IT WAS INDICATED TO HAVE BEEN AN OUT-PATIENT SURGERY. PATIENT OUTCOME WAS REPORTED AS A NON-SERIOUS ILLNESS/INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195701 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention