BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4123278 · Received September 26, 2014

    Report

    Report Number
    3004209178-2014-17842
    Event Type
    Injury
    Date Received
    September 26, 2014
    Report Date
    September 5, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 37092, PRODUCT TYPE ACCESSORY. PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3093-28. LOT# VA022Q8, IMPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS A 50 PERCENT OR GREATER SYMPTOM REDUCTION. THE CAUSE THE EVENT WAS DETERMINED AND IT WAS AND WASN¿T DEVICE RELATED. REPROGRAMMING WAS NEEDED AND THEY MET WITH THE MANUFACTURER REPRESENTATIVE. THE TROUBLESHOOTING, INTERVENTIONS, OR OTHER ACTIONS TAKEN TO MITIGATE OR RESOLVE THE EVENT WERE REPROGRAMMING AND REEDUCATION ON (B)(6) 2014. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Description of Event or Problem · 1

    THE PATIENT REPORTED NO STIMULATION SENSATION AND DID NOT KNOW WHEN SHE STOPPED FEELING STIM. THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AND RETURNED OF SYMPTOMS THAT STARTED A YEAR AGO. IT WAS INDICATED THAT THEIR THERAPY WAS NOT WORKING AS EXPECTED. IT WAS REPORTED 5 DAYS LATER THAT PATIENT HAD HEMORRHAGIC CYSTITIS AND WAS ON ANTIBIOTICS. THE PATIENT EXPERIENCED SYMPTOMS OF URINARY FREQUENCY AND URGENCY. THE PATIENT APPOINTMENT WAS SCHEDULED FOR 2014-(B)(6). IT WAS FURTHER REPORTED ON 2014-(B)(6) THAT THE INTERSTIM WAS NOT WORKING. SHE WAS SHE WAS HAVING PROBLEM GOING TO UROLOGIST AND HE WANTED IT EITHER ON OR OFF AND SHE DID KNOW HOW TO DO THAT. THE PATIENT STILL REPORTED A LOSS OF THERAPEUTIC EFFECT. A PROBLEM WITH THE PATIENT PROGRAMMER WAS REPORTED. THE PATIENT STATED THAT PROGRAMMER WOULD NOT LIGHT UP AND PATIENT HAD NOT CHANGE BATTERIES. ADDITIONAL INFORMATION CAME IN ON 2014-(B)(6) THAT PATIENT HAD NEW BATTERIES IN PROGRAMMER AS PREVIOUS DISCUSSED WITH MANUFACTURER REPRESENTATIVE. IT WAS NOTED THAT PATIENT WAS NOT ABLE TO MAKE ADJUSTMENT WITH ANTENNA ATTACHED BUT WAS ABLE TO COMMUNICATE WITH PROGRAMMER AFTER DISCONNECTING THE ANTENNA. THE PATIENT WAS AT 0.6 AND COULD SEE THE LIGHTENING BOLT. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. A FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602832 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR