BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2657695 · Received July 17, 2012

    Report

    Report Number
    3004209178-2012-05698
    Event Type
    Malfunction
    Date Received
    July 17, 2012
    Report Date
    June 20, 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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V822732, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD PAIN AT HER INTERNAL NEUROSTIMULATOR (INS) SITE WHEN LYING ON HER BACK. THE PATIENT STATED THE AREA WAS TENDER TO THE TOUCH BUT NOT RED OR SWOLLEN. A KNOT WAS PRESENT WHICH THE PATIENT STATED SHE WAS TOLD WAS NORMAL. THE PATIENT STATED THE STIMULATION WAS "PRETTY GOOD" OVERALL. THE PATIENT STATED THE STIMULATION FELT WAS INCREASING OVER THE LAST TWO DAYS BUT HER SETTING REMAINED UNCHANGED. THE PATIENT STATED THERE WAS NO KNOWN ACCIDENT OR INDICATION RELATED TO THIS COMPLAINT. THE PATIENT WAS REPROGRAMMED DECREASING THE VOLTAGE, HOWEVER, WITH THE DECREASED VOLTAGE THE PATIENT COULD NO LONGER FEEL THE STIMULATION. THE PATIENT TRIED TO INCREASE THE VOLTAGE BUT WAS UNSURE IF SHE DID IT CORRECTLY. THE PATIENT WAS ADVISED TO CONTACT HER HEALTH CARE PROFESSIONAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT THAT REPORTED THEY HAD RECEIVED ASSISTANCE FROM THEIR DOCTOR OR A MANUFACTURER'S REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. HOWEVER, THE PATIENT ALSO NOTED THAT THEY STILL HAD CONCERNS REGARDING THE DEVICE OR THERAPY AND WERE WORKING WITH THEIR DOCTOR OR A MANUFACTURER'S REPRESENTATIVE. ADDITIONAL INFORMATION WAS ALSO RECEIVED FROM THE PATIENT'S HCP WHICH REPORTED THAT THEY WERE UNAWARE OF ANY ISSUES WITH THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS). IMPEDANCE VALUES WERE NORMAL AND NO INTERVENTIONS WERE TAKEN BY THE PHYSICIAN. THE PATIENT STATED THAT THE PAIN RESOLVED ON ITS OWN AND HAD NO PAIN ON THE DAY THEY MET WITH THE PHYSICIAN. THE PATIENT HAD DISCUSSED THE ISSUE WITH THE MANUFACTURER'S REPRESENTATIVE, AND NOT WITH THE PHYSICIAN. THE PATIENT DID NOT REQUIRE HOSPITALIZATION AND SUFFERED NO INJURY. THE PATIENT RECOVERED WITHOUT SEQUELAE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    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