BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVO®, TYPE NUMBER 208

    MDR report key: 15614775 · Received October 17, 2022

    Report

    Report Number
    3015223097-0722-00077
    Event Type
    Injury
    Date Received
    October 17, 2022
    Date of Event
    September 6, 2022
    Report Date
    October 17, 2022
    Manufacturer
    ATLANTIC THERAPEUTICS LTD
    Product Code
    QAJ
    PMA / PMN Number
    K192357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2022, A CUSTOMER REPORTED EXPERIENCING BLADDER SPASMS, BEGINNING WEEK COMMENCING (B)(6), FOLLOWING USE OF THE INNOVO DEVICE. THE CUSTOMER DETAILED USE OF THE DEVICE 8 TIMES OVER 3 DAY, AND THE NEED TO CONTACT HER DOCTOR WHO ADVISED TO STOP USE OF THE INNOVO DEVICE. THE CUSTOMER USED IBUPROFEN AND CEASED USE OF THE DEVICE. THE USER MANUAL WHICH IS PROVIDED WITH THE INNOVO DEVICE IDENTIFIES THAT THE USE OF THE DEVICE SHOULD BE LIMITED TO ONCE PER DAY WITH A RECOMMENDED 5 SESSIONS PER WEEK, ALLOWING FOR A 2 DAY REST PERIOD. AS SUCH, IT IS POSSIBLE THAT MISUSE OF THE DEVICE HAS CONTRIBUTED TO THE EVENT AS REPORTED BY THE CUSTOMER. WE HAVE REQUESTED RETURN OF THE DEVICE FOR INVESTIGATION AND ARE AWAITING ITS ARRIVAL AT ATLANTIC THERAPEUTICS LTD. DUE TO THE LIMITED INFORMATION AVAILABLE AT THIS STAGE OF OUR INVESTIGATION, WE ARE NOT ABLE TO DETERMINE IF THIS EVENT IS REPORTABLE, HOWEVER, DUE TO A PREDISPOSITION TO REPORT, WE HAVE MADE THE DECISION TO SUBMIT AN INITIAL MDR TO THE FDA WHILE OUR INVESTIGATION PROCEEDS. WE WILL PROVIDE THE FDA WITH UPDATES ON OUR INVESTIGATION, INCLUDING DETAILS OF ANY ROOT CAUSE ANALYSIS, CORRECTIVE AND/OR PREVENTATIVE ACTIONS TAKEN AND ANY SUBSEQUENT DETERMINATION OF EVENT REPORTABILITY.

    Additional Manufacturer Narrative · 0

    UPDATE - EVENT NO LONGER CONSIDERED REPORTABLE: ON THIS OCCASION THE CUSTOMER REPORTED EXPERIENCING BLADDER SPASMS FOLLOWING USE OF THE INNOVO DEVICE AND WAS ADVISED BY HER DOCTOR TO STOP USE OF THE DEVICE. DUE TO A PREDISPOSITION TO REPORT, AN INITIAL MDR WAS SUBMITTED WHILE WE PROGRESSED OUR INVESTIGATION. WE NOTED THAT THE CUSTOMER REPORTED USE OF THE DEVICE 8 TIMES OVER 3 DAYS, WHICH IS CONSIDERED DEVICE MISUSE. THE IFU WHICH ACCOMPANIES THE DEVICE INSTRUCTS PATIENTS TO USE THE DEVICE ONLY ONCE PER DAY, AND UP TO 5 DAYS PER WEEK, WITH TWO REST DAYS. IN ADDITION, WE HAVE MADE ATTEMPTS TO CONTACT THE CUSTOMER TO OBTAIN AN UPDATE ON HER CURRENT CONDITION, AND TO DATE HAVE HAD NO RESPONSE. WE ENGAGED OUR CLINICAL EXPERT TEAM TO REVIEW THE INFORMATION AVAILABLE AND HAVE BEEN ADVISED THAT UNDER NORMAL USE CONDITIONS THE DEVICE CANNOT BE EXPECTED TO CAUSE OR CONTRIBUTE TO BLADDER SPASMS AS REPORTED BY THE CUSTOMER. HOWEVER, BLADDER SPASMS ARE TYPICALLY ASSOCIATED WITH URGE INCONTINENCE AND A NUMBER OF OTHER MEDICAL CONDITIONS WHICH COULD BE AFFECTING THE CUSTOMER. IN ADDITION, THE CLINICAL EXPERT TEAM ACKNOWLEDGED THAT GIVEN THE DEVICE MISUSE REPORTED BY THE CUSTOMER, IT IS POSSIBLE THAT THE CUSTOMER ALSO USED THE DEVICE WITHOUT EMPTYING HER BLADDER (AS PER INSTRUCTIONS), IN WHICH CASE, THE EXCESSIVE USE OF THE DEVICE ALONG WITH THE FULL BLADDER COULD INHIBIT THE MICTURITION REFLEX (THE URGE TO EMPTY YOUR BLADDER) AND IT IS THEREFORE POSSIBLE THAT THIS COULD LEAD TO HER BLADDER MUSCLE CONTRACTING AS A CUE TO EMPTY THE BLADDER. AS WE HAVE HAD NO RESPONSE FROM THE CUSTOMER, WE ARE UNABLE TO CONFIRM IF THIS ASSESSMENT APPLIES OR IF ANY OF THE IDENTIFIED MEDICAL CONDITIONS MAY BE AFFECTING THE CUSTOMER IN THIS CASE. HAVING ASSESSED THE REPORT AND TAKEN ACCOUNT OF CLINICAL EXPERT OPINION, OUR OWN PRELIMINARY ASSESSMENT AND ALL OTHER INFORMATION AVAILABLE TO US, AND, AS THE CUSTOMER HAS NOT RESPONDED TO OUR REQUESTS FOR MORE INFORMATION, IT IS NOT POSSIBLE TO CONFIRM IF THE REPORTED EVENT IS ONGOING, IN WHICH CASE WE CANNOT CONSIDER THIS EVENT TO REPRESENT A SERIOUS INJURY. THEREFORE, AS THE EVENT REPRESENTS DEVICE MISUSE AND IS NOT CONSIDERED A SERIOUS INJURY OR PERMANENT IMPAIRMENT, THE EVENT IS NO LONGER CONSIDERED REPORTABLE TO THE FDA. IN LINE WITH INTERNAL PROCEDURE, WE WILL REVIEW OUR DEVICE RISK MANAGEMENT TO DETERMINE IF ANY UPDATES ARE REQUIRED IN RESPONSE TO THIS REPORT.

    Description of Event or Problem · 0

    UNCONFIRMED REPORT OF BLADDER SPASMS FOLLOWING USE OF INNOVO DEVICE. NO MEDICAL REPORTS HAVE BEEN RECEIVED AND INVESTIGATION IS ONGOING. MDR SUBMITTED DUE TO PREDISPOSITION TO REPORT.

    Description of Event or Problem · 0

    FINAL MDR - DEVICE FOUND TO BE COMPLIANT AND CUSTOMER REPORT UNCONFIRMED. EVENT IS NO LONGER CONSIDERED REPORTABLE. UNCONFIRMED REPORT OF BLADDER SPASMS FOLLOWING USE OF INNOVO DEVICE. NO MEDICAL REPORTS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2047601 INNOVO®, TYPE NUMBER 208 CUTANEOUS ELECTRODE STIMULATOR FOR URINARY INCONTINENCE QAJ ATLANTIC THERAPEUTICS LTD 208

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other