BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3018325 · Received March 22, 2013

    Report

    Report Number
    3004209178-2013-04153
    Event Type
    Injury
    Date Received
    March 22, 2013
    Report Date
    March 6, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT# V861091, 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 THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND HAD A RETURN OF SYMPTOMS A FEW WEEKS PRIOR TO THE REPORT. THE REPORTER INDICATED THAT SEVERAL ATTEMPTS HAD BEEN MADE TO TRY TO MAKE ADJUSTMENTS WITH THE PATIENT PROGRAMMER BUT THE PATIENT COULD NOT FEEL STIMULATION. THE REPORTER STATED THAT THE PATIENT WAS SEEN BY HER HEALTHCARE PROVIDER (HCP) THE DAY PRIOR TO THE REPORT AND WAS INFORMED THAT THERE WAS AN 'ISSUE' WITH THE LEAD. THE PATIENT WAS INSTRUCTED TO KEEP STIMULATION OFF. IT WAS NOTED THAT THE PATIENT WAS SCHEDULED FOR REPLACEMENT SURGERY ON (B)(6) 2013. NO FURTHER INFORMATION WAS REPORTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE "ISSUE" WITH THE LEADS WAS THAT THEY WERE "NOT WORKING." THE PATIENT'S PHYSICIAN NOTED THAT THE CASE TO LEAD READINGS WITH ELECTRODES 0, 1, 2, AND 3 WERE "ABNORMAL" AND "ALL ELEVATED." THE PATIENT'S SYMPTOMS WERE NOTED AS "RECURRENT BLADDER SYMPTOMS." THE PATIENT'S PHYSICIAN STATED THAT THE DEVICE REMAINED OFF ON (B)(6) 2013 AND THE "PATIENT WOULD NEED EXPLANT AND REPLACEMENT" OF THE DEVICE. IT WAS REPORTED ON (B)(6) 2013 THAT THE PATIENT'S LEAD HAD BROKEN "A LITTLE OVER AN HOUR AGO." IT WAS ALSO NOTED THAT THE PATIENT'S SURGERY FOR (B)(6) 2013 HAD BEEN CANCELLED AND HAD YET TO BE RESCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119752 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention