BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVO®, TYPE NUMBER 207

    MDR report key: 15603062 · Received October 14, 2022

    Report

    Report Number
    3015223097-0922-00064
    Event Type
    Injury
    Date Received
    October 14, 2022
    Date of Event
    July 2, 2021
    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
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 23RD OF AUGUST 2022, A UK CUSTOMER CONTACTED THE ATLANTIC THERAPEUTICS CUSTOMER CARE TEAM. THE CUSTOMER ADVISED THAT HIS WIFE, HAD USED THE INNOVO DEVICE 5 TIMES IN JUNE OF 2021 AND AT THAT TIME EXPERIENCED A SHARP SHOCK. THE CUSTOMER REPORTS THAT SINCE THE OCCURRENCE OF THE REPORTED SHOCK, HIS WIFE HAS BEEN UNABLE TO WALK PROPERLY, OR CLIMB STAIRS, AND IS STILL EXPERIENCING PAIN, WHICH SPREAD FROM HER GROIN TO HER RIGHT KNEE AND FOOT, THE DAY AFTER THE SHOCK EVENT. UPON BEING MADE AWARE OF THIS COMPLAINT, A REVIEW OF THE INFORMATION PROVIDED, WITH REGARDS TO REPORTABILITY OF THE EVENT, WAS COMPLETED. INITIALLY, IT WAS DETERMINED THAT THE EVENT WAS NOT REPORTABLE AND AS SUCH AN MDR WAS NOT SUBMITTED TO THE FDA AND THE COMPLAINT WAS PROGRESSED IN LINE WITH OUR INTERNAL COMPLAINT HANDLING PROCESS. IT HAD BEEN EVALUATED THAT THE INFORMATION PROVIDED BY THE CUSTOMER DID NOT SUPPORT A CATEGORIZATION OF THE EVENT AS A PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, AND THEREFORE THE EVENT WAS NOT CONSIDERED REPORTABLE. THIS POSITION, WAS SUPPORTED BY OUR CLINICAL EXPERT TEAM, WHO REVIEWED THE AVAILABLE INFORMATION AND CONCLUDED THAT IT WAS UNLIKELY THAT THE INNOVO DEVICE HAD CAUSED OR CONTRIBUTED TO THE EVENT AS REPORTED BY THE CUSTOMER. HOWEVER, IN LINE WITH INTERNAL PROCESSES, WE UNDERTAKE TO REVIEW REPORTABILITY OF COMPLAINTS THROUGHOUT THE INVESTIGATION OR WHEN SIMILAR REPORTS ARE RECEIVED. TO THIS END, A FURTHER REVIEW WAS COMPLETED ON 8TH OF SEPTEMBER, AT WHICH TIME, WE DETERMINED THAT THE EVENT MAY BE REPORTABLE AND AN INITIAL MDR SHOULD BE SUBMITTED WHILE WE AWAIT RETURN OF THE DEVICE FOR INVESTIGATION AND PROGRESSION OF THE COMPLAINT INVESTIGATION. AS THE EVENT OCCURRED IN THE UK, AND INITIAL MIR WILL ALSO BE SUBMITTED TO THE MHRA. AT THIS STAGE OF OUR INVESTIGATION IT IS NOT POSSIBLE TO VERIFY THE EVENTS AS REPORTED BY THE CUSTOMER, INSPECT THE DEVICE OR CONCLUSIVELY STATE THE ROOT CAUSE OF THESE EVENTS, THEREFORE, THE RETURN OF THE DEVICE HAS BEEN REQUESTED AND THE INVESTIGATION IS CONTINUING. ATLANTIC THERAPEUTICS LTD WILL PROVIDE UPDATE REPORTS TO THE FDA IN LINE WITH THE FDAS REQUIREMENTS, UNTIL WE ARE ABLE TO VERIFY THE ROOT CAUSE AND SUBMIT A FINAL MDR FOR REVIEW. THE EVENT, AS REPORTED BY THE CUSTOMER, OCCURED IN THE UK, HOWEVER, AS ATLANTIC THERAPEUTIC ALSO MARKETS THIS DEVICE IN THE US, AN MDR HAS BEEN SUBMITTED TO THE FDA IN ADDITION TO THE MIR WHICH HAS BEEN SUBMITTED TO THE UK MHRA.

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2022, A UK CUSTOMER CONTACTED THE ATLANTIC THERAPEUTICS CUSTOMER CARE TEAM. AN INITIAL MDR WAS SUBMITTED WHILE WE AWAITED RETURN OF THE DEVICE FOR INVESTIGATION AND PROGRESSION OF THE COMPLAINT INVESTIGATION. AS THE EVENT OCCURRED IN THE UK, AN INITIAL MIR WAS ALSO SUBMITTED TO THE MHRA. FOLLOWING OR INVESTIGATION, IT HAS NOT BEEN POSSIBLE TO VERIFY THE EVENTS AS REPORTED BY THE CUSTOMER. ON THIS OCCASION, THE CUSTOMER STATED THAT FOLLOWING USE OF THE INNOVO DEVICE FIVE TIMES IN (B)(6) 2021, SYMPTOMS HAVE BEEN ONGOING FOR MORE THAN A YEAR, DURING WHICH TIME NO MEDICAL INTERVENTION HAS BEEN SOUGHT. 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. UNDER EU & UK REQUIREMENTS, AND IN ACCORDANCE WITH MEDDEV 1.12-1 REV 8, THE EVENTS AS REPORTED BY THE CUSTOMER MEET A AND C BUT DO NOT MEET B. 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. 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. HAVING OCCURRED IN THE UK, A FINAL MIR HAS ALSO BEEN SUBMITTED TO THE MHRA DETAILING OUR RE-ASSESSMENT OF THIS EVENT AS NOT REPORTABLE.

    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. NO MEDICAL REPORTS HAVE BEEN RECEIVED AND INVESTIGATION IS ONGOING. MDR SUBMITTED DUE TO PREDISPOSITION TO REPORT, NOW CONSIDERED NOT REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1972619 INNOVO®, TYPE NUMBER 207 CUTANEOUS ELECTRODE STIMULATOR FOR URINARY INCONTINENCE QAJ ATLANTIC THERAPEUTICS LTD, 207

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Other