BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2950403 · Received February 8, 2013

    Report

    Report Number
    3004209178-2013-01481
    Event Type
    Injury
    Date Received
    February 8, 2013
    Report Date
    January 25, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# VA053WY, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT PHYSICIAN CONTACTED THAT PATIENT AND IT WAS DECIDED THAT NOTHING FURTHER WILL BE DONE AT THIS POINT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NO STIMULATION SENSATION AND HAD NOT HAD ANY THERAPY RESPONSE SINCE IMPLANT. IT WAS NOTED THAT THE PATIENT HAD A GOOD RESPONSE DURING THE TRIAL. THE MANUFACTURER REPRESENTATIVE INDICATED THAT HE GAVE THE PATIENT FOUR PROGRAMS HAD HIM TURN ON STIMULATION LATER THE DAY OF IMPLANT AFTER ANESTHESIA HAD WORN OFF. THE PATIENT CALLED THE DAY AFTER IMPLANT AND SAID HE COULDN'T FEEL STIMULATION. THE PATIENT WAS SEEN IN THE CLINIC THE FOLLOWING DAY AND WASN'T ABLE TO FEEL STIMULATION ON ANY OF THE FOUR PROGRAMS. IT WAS NOTED THAT THE PATIENT HAD STIMULATION SET TO 8.5V ON THE PROGRAM HE HAD BEEN SENT HOME WITH, SO THEY TURNED IT DOWN. IT WAS REPORTED THAT DURING IMPLANT THE HCP DID NOT GET A GOOD MOTOR RESPONSE WITH THE 0/1 PAIR, BUT DID GET A GOOD RESPONSE WITH THE 2 AND 3 ELECTRODES AT 4V. TRYING THE LEAD ON THE OTHER SIDE YIELDED SIMILAR RESULTS, AND THE HCP WAS CONTENT WITH THE MOTOR RESPONSE THEY GOT. POST-OPERATIVE IMAGING LOOKED GOOD. IT WAS THOUGHT THAT THE PATIENT WAS TRYING PROGRAM 3-/1+ AT AROUND 5.0V. THE PATIENT WAS TRYING OTHER PROGRAMS AND PLANNED TO SEE HOW THEY WENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT AN X-RAY CONFIRMED THE LEAD WAS NOT IN THE S3 FORAMEN. ACCORDING TO THE HCP IT WAS IN THE S4, AND THE HCP WAS SCHEDULING THE PATIENT FOR A WIRE REVISION. 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
    54356 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention