BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVO®, TYPE NUMBER 208

    MDR report key: 15603061 · Received October 14, 2022

    Report

    Report Number
    3015223097-0722-00065
    Event Type
    Injury
    Date Received
    October 14, 2022
    Date of Event
    September 6, 2022
    Report Date
    October 27, 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 PAIN AND REDUCED MOBILITY FOLLOWING USE OF THE INNOVO DEVICE. THE CUSTOMER DETAILED USE OF THE DEVICE BETWEEN (B)(6) 2022 AND THE DATE OF THE REPORT, AND STATES THAT THE SHORTS CAUSED "AN ISSUE WITH EXTREME PAIN AND PINCHED NERVES IN LEGS". IN ADDITION, THE CUSTOMER DESCRIBED THE PAIN AS CONSTANT AND STATED THAT HER MOBILITY HAS BEEN "SEVERELY LIMITED". THE CUSTOMER ALSO DESCRIBED CONTINUING WITH USE OF THE DEVICE, AFTER THE ONSET OF SYMPTOMS, WHICH HAS WORSENED THE REPORTED CONDITION. THE USER MANUAL WHICH IS PROVIDED WITH THE INNOVO DEVICE IDENTIFIES THAT THE USE OF MUSCLE STIMULATION DEVICES AT A HIGH INTENSITY CAN BE ASSOCIATED WITH MINOR AND TRANSIENT DISCOMFORT OR PAIN, AND INSTRUCTS THE USER TO ENSURE THAT THEIR USE OF THE INNOVO DEVICE IS AT A LEVEL WHICH IS COMFORTABLE. THE MANUAL FURTHER CONFIRMS THAT AN EFFECTIVE TREATMENT SESSION SHOULD NOT CAUSE UNDUE DISCOMFORT OR PAIN. 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

    THE CUSTOMER DETAILED USE OF THE DEVICE BETWEEN (B)(6) 2022 AND (B)(6)2022. THE CUSTOMER STATES THAT THE SHORTS CAUSED "AN ISSUE WITH EXTREME PAIN AND PINCHED NERVES IN LEGS". IN ADDITION, THE CUSTOMER DESCRIBED THE PAIN AS CONSTANT AND STATED THAT HER MOBILITY HAS BEEN "SEVERELY LIMITED". THE CUSTOMER DESCRIBED CONTINUING WITH USE OF THE DEVICE, AFTER THE ONSET OF SYMPTOMS, WHICH HAS WORSENED THE REPORTED CONDITION. THE USER MANUAL WHICH IS PROVIDED WITH THE INNOVO DEVICE IDENTIFIES THAT THE USE OF MUSCLE STIMULATION DEVICES AT A HIGH INTENSITY CAN BE ASSOCIATED WITH MINOR AND TRANSIENT DISCOMFORT OR PAIN AND INSTRUCTS THE USER TO ENSURE THAT THEIR USE OF THE INNOVO DEVICE IS AT A LEVEL WHICH IS COMFORTABLE. THE MANUAL FURTHER CONFIRMS THAT AN EFFECTIVE TREATMENT SESSION SHOULD NOT CAUSE UNDUE DISCOMFORT OR PAIN. DUE TO A PREDISPOSITION TO REPORT, WE MADE THE DECISION TO SUBMIT AN INITIAL MDR TO THE FDA WHILE OUR INVESTIGATION PROCEEDED. THE CUSTOMER HAS NOT RESPONDED TO OUR REQUESTS FOR MORE INFORMATION AND OUR CLINICAL EXPERT TEAM HAS ASSESSED THE AVAILABLE INFORMATION AND CONCLUDED THAT THE INNOVO DEVICE CANNOT BE EXPECTED TO HAVE CONTRIBUTED TO OR CAUSED THE ADVERSE EFFECTS REPORTED BY THE CUSTOMER. FOR THIS REASON, WE HAVE RE-EVALUATED THE REPORTABILITY OF THIS EVENT AND CONCLUDED THAT THE EVENTS AS REPORTED BY THE CUSTOMER DO NOT MEET THE REQUIREMENTS TO BE CONSIDERED A REPORTABLE EVENT. THE INNOVO DEVICE IS NOT SUSPECTED TO BE A CONTRIBUTORY CAUSE OF THE INCIDENT, HAVING ASSESSED THE REPORT AND TAKEN ACCOUNT OF CLINICAL EXPERT OPINION, OUR OWN PRELIMINARY ASSESSMENT AND ALL OTHER INFORMATION AVAILABLE TO US. IN ADDITION, 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. UNDER FDA GUIDANCE, MANUFACTURERS ARE REQUIRED TO REPORT WHEN THEY LEARN THAT ANY OF THEIR DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY. AS WE HAVE DETERMINED THAT THE INNOVO DEVICE IS NOT A CONTRIBUTORY CAUSE OF THE EVENT AS DESCRIBED BY THE CUSTOMER, THE EVENT IS NO LONGER CONSIDERED REPORTABLE TO THE FDA.

    Description of Event or Problem · 0

    UNCONFIRMED REPORT OF PAIN AND REDUCED MOBILITY 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

    UNCONFIRMED REPORT OF PAIN AND REDUCED MOBILITY FOLLOWING USE OF INNOVO DEVICE. UPDATE TO MDR - NO LONGER CONSIDERED REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1972618 INNOVO®, TYPE NUMBER 208 CUTANEOUS ELECTRODE STIMULATOR FOR URINARY INCONTINENCE QAJ ATLANTIC THERAPEUTICS LTD 208

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Other