BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3092136 · Received May 3, 2013

    Report

    Report Number
    3004209178-2013-07254
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Report Date
    April 17, 2013
    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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3 093-28, LOT# V979673, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE EVENT AS LOW BACK PAIN. HIGH IMPEDANCE GREATER THAN 4000 OHMS WAS NOTED ON LEADS AT 02 AND 03. AN X-RAY WAS TAKEN ON (B)(6) 2013 NOTING THAT THE BATTERY WAS POSTERIOR, LEAD PLACED NEAR S3, AND L5-S1 GRADE 1 SPONDYLOLISTHESIS. REPROGRAMMING WAS PERFORMED ON (B)(6) 2013 WHEREIN THE DEVICE WAS TURNED OFF AND NOTED UNABLE TO REACH PATIENT SO FAR FOR 0.0 V TO REPROGRAM. THE PATIENT SYMPTOMS WERE NOTED AS ¿SHOCKING¿ LOW BACK PAIN RADIATING DOWN BACK OF LEFT LEG AND VAGINA WITH IMPLANT TURNED OFF. THE PATIENT DID NOT REQUIRE HOSPITALIZATION AND PATIENT OUTCOME REPORTED AS NO INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A SHOCKING SENSATION "EVERY 8 SECONDS" IN HER VAGINAL AREA. THE DEVICE WAS TURNED OFF AND AT 0V BUT THE PATIENT WAS STILL EXPERIENCING SHOCKING. IT WAS NOTED THAT THE PATIENT WAS IN THE EMERGENCY ROOM (ER) AT THE TIME OF THE CALL. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193697 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR