BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3984167 · Received August 6, 2014

    Report

    Report Number
    3004209178-2014-14024
    Event Type
    Injury
    Date Received
    August 6, 2014
    Report Date
    July 30, 2014
    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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: REVIEWED AND CONFIRMED / UPDATED RFR, HAZARD, AND CONCLUSION CODES. A GOOD FAITH EFFORT FOR FOLLOW-UP WAS COMPLETED. THE INS REMAINS IMPLANTED. THE EVENT DID NOT ALLEGE A POTENTIAL MANUFACTURING ISSUE; THEREFORE, A DHR REVIEW WAS NOT REQUIRED FOR THE INS. THE EVENT WAS REVIEWED FOR EXISTING INVESTIGATIONS AND NONE APPLIED. THE EVENT WAS REVIEWED FOR KNOWN INHERENT RISKS LISTED IN PRODUCT LABELING AND EVENT APPLIES TO KNOWN EVENT TRENDS ADVERSE CHANGE IN VOIDING FUNCTION - BLADDER AND PAIN/DISCOMFORT BECAUSE THE PATIENT REPORTED AN EPISODE OF INCONTINENCE AND A BURNING PAIN SENSATION. REVIEWED FOR ESCALATION TO NCET AND ESCALATION WAS NOT REQUIRED. EVENT IS INCLUDED IN MONITORING FOR KNOWN INHERENT RISKS AS DISCLOSED IN PRODUCT LABELING. THE INVESTIGATION OF THE INS IS INCONCLUSIVE BECAUSE THE CAUSE OF THE PATIENT'S SYMPTOMS AND OUTCOME ARE UNKNOWN. CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT # VA0DJH8, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT # VA0EXJP, PRODUCT TYPE LEAD; PRODUCT ID 3889-28, LOT # VA0DJH8, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTS THAT THE PATIENT MEETS WITH HER CURRENT PHYSICIAN. SHE HAS NOT MET WITH REPRESENTATIVE SINCE BEING A PATIENT OF OTHER HEALTHCARE PROVIDER. THE REPRESENTATIVE WAS UNAWARE OF ANY CHANGES IN THERAPY OR PROGRAMMING.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. IT WAS STATED WHEN THE PATIENT WOKE UP SHE DIDN¿T FEEL IT, SO SHE TURNED IT UP, AND THEN SHE HAD COFFEE AND LEAKED SO SHE TURNED IT UP AGAIN AND FELT A BURNING PAIN IN HER VAGINA. THE STIMULATION WAS SET AT 0.9 AT THE TIME OF REPORT AND IT WAS TURNED DOWN TO 0.8 OR 0.7. THE PATIENT WAS REDIRECTED TO HER HEALTHCARE PROVIDER. IT WAS REPORTED THE PATIENT STILL HAD CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR DOCTOR OR REPRESENTATIVE ON (B)(6) 2013. THE PATIENT STATED THE IMPLANT WAS NOT WORKING LIKE THE TRIAL AND THEY WERE UNAWARE OF THE DIFFERENT PROGRAMS. ADDITIONAL INFORMATION RECEIVED REPORTS THE PATIENT SAID THAT SHE HAD HER LEAD WIRE MOVED IN NOVEMBER AND REPLACED IN JANUARY. THE PATIENT SAID THAT WHEN SHE WAS IMPLANTED IT DIDN'T HELP AND SHE COULDN'T COMFORTABLY INCREASE STIMULATION. THE PATIENT SAID THAT SHE HAD MANY REPROGRAMMING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTS THE PATIENT WAS HAVING SYMPTOM IMPROVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461879 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention