BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2211124 · Received August 8, 2011

    Report

    Report Number
    3004209178-2011-06157
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    June 1, 2011
    Report Date
    July 13, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD BACK SURGERY ON (B)(6) 2011 AND STATED "THEY HURT HER TAILBONE" AND IT MIGHT HAVE BEEN CRACKED OR SHE MAY HAVE HAD A SPINAL FLUID LEAK. THE PATIENT WAS GOING TO SEE THE SURGEON ON (B)(6) 2011 TO HAVE THE PROBLEM CORRECTED. FOUR WEEKS AFTER SURGERY, THE PATIENT FELL "DOWN TO HER KNEES AND FLAT ON HER NOSE." FOLLOWING THE FALL, THE PATIENT DID NOT FEEL A STIMULATION SENSATION IN HER VAGINA. THE PATIENT TURNED HER STIMULATION UP, BUT IT CAUSED "PAIN IN HER RUMP" SO SHE TURNED IT BACK DOWN. THE PATIENT HAD PAIN IN HER TAILBONE EVEN AFTER TURNING STIMULATION DOWN. THE PATIENT HAD "BAD LEAKAGE" AT NIGHT DUE TO TAKING PAIN MEDICATION. AFTER FOLLOWING THE FALL, PAIN IN HER LOWER BACK BEGAN AND WORSENED OVER DAYS. THE PATIENT'S PAIN MEDICATION WAS INCREASED, HOWEVER, A WEEK LATER, THE PAIN WAS SO SEVERE THAT SHE WAS ADMITTED TO THE HOSPITAL AND HAD A CT SCAN. IT WAS DETERMINED THAT THE PATIENT HAD A CRACKED TAILBONE AND SPINAL FLUID OVER HER TAILBONE. 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 EZW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED:| IMPLANTED:| LEAD: MODEL 3889, LOT# V625723| PROGRAMMER: MODEL 3037, LOT# NJD122866N