BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2842892 · Received November 21, 2012

    Report

    Report Number
    3004209178-2012-10677
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    August 16, 2012
    Report Date
    October 26, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# VA00LYG, IMPLANTED: (B)(6) 2012. 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 PATIENT WAS GETTING A TINGLING/NEEDLES POKING FEELING FROM THE WAIST TO THE TOE ON THE LEFT SIDE WHILE STIMULATION IS TURNED ON AND OFF. PATIENT WAS IN A LOT OF PAIN. PATIENT WAS IN CAR ACCIDENT ON (B)(6) 2012, BROUGHT IN TO THE EMERGENCY ROOM AND ADMITTED TO THE HOSPITAL. PATIENT WAS UNSURE IF PAIN WAS ASSOCIATED WITH IMPLANTABLE NEUROSTIMULATOR (INS) OR WITH CAR ACCIDENT. SYMPTOMS OF URGENCY AND NOT ABLE TO CONTROL FLOW RETURNED. DURING DOCTOR APPOINTMENT ON (B)(6), DOCTOR CONFIRMED DEVICE DID NOT MOVE. MEDTRONIC REPRESENTATIVE HELPED TO REPROGRAM DEVICE USING PATIENT PROGRAMMER TO PROGRAM 1 AT 6.2 AND TINGLE/ NEEDLE PAIN FROM WAIST TO TOE WAS GONE. PATIENT WAS CONCERNED THAT THE IMPACT OF THE ACCIDENT DISTURBED THE IMPLANT. PATIENT WAS HAVING PAIN ON ALL THE LEFT SIDE OF HIS BODY. A HERNIA WAS SUSPECTED BECAUSE PATIENT HAD A GROWTH ON THE LOWER LEFT STOMACH AREA. DURING DOCTOR APPOINTMENT ON (B)(6), DOCTOR DID NOT SEE A HERNIA BUT PATIENT WAS HAVING PAIN ASSOCIATED TO MOVEMENTS. PATIENT ALSO HAD PARKINSON. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 00067 YR Required Intervention