BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3070799 · Received April 22, 2013

    Report

    Report Number
    3004209178-2013-06644
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    April 2, 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
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3093-33, LOT# V758541, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-33, LOT# V758541, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED ON (B)(6) 2012 THAT FOR THE LAST 4-5 DAYS, THE PATIENT HAD EXPERIENCED INTERSTITIAL CYSTITIS "FLARES" WITH NOT AS MUCH FREQUENCY ISSUES. THE PATIENT HAD BEEN REPROGRAMMED SEVERAL TIMES BY THE NURSES AT HER PHYSICIAN'S OFFICE AND IT HAD NOT WORKED. ADDITIONAL INFORMATION ON (B)(6) 2012 NOTED THAT THE PATIENT HAD BEEN REPROGRAMMED THAT MORNING. ADDITIONAL INFORMATION ON (B)(6) 2013 NOTED THAT THE PATIENT HAD CONCERNS WITH THEIR DEVICE (HAVE FREQUENCY LATELY). AN APPT OF (B)(6) 2012 AND WAS NOT RESOLVED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013 NOTED THAT THE CAUSE OF THE EVENT WAS WORSENED DISEASE PROCESS. ABNORMAL IMPEDANCE MEASUREMENTS WERE NOTED: LEFT IMPEDANCE @ 0 AND 3 WAS GREATER THAN 4000. RIGHT IMPEDANCE @ C AND 3, 1 AND 3, 2 AND 3 AND 0 AND 3 WAS GREATER THAN 4000. PROGRAMMING WAS NOT HELPING. NO SURGICAL INTERVENTION HAD OCCURRED. REPROGRAMMING ON (B)(6) 2013 WAS NOTED AS: CHECK IMPEDANCE AND BATTERY BILATERALLY. ADJUSTED SOME MED. PATIENT WAS FEELING STIMULATION IN BICYCLE SEAT AREA. SIGNS AND SYMPTOMS ASSOCIATED WITH THE EVENT WERE NOTED AS FREQUENCY, URGENCY, NOCTURIA AND PAIN. HOSPITALIZATION WAS NOT REQUIRED. SEE ALSO MANUFACTURER'S REPORT # 3004209178-2013-06642.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT HAD CONCERNS WITH THEIR DEVICE OR THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171267 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR