inforMED
InjuryQAJ

INNOVO, TYPE NUMBER 208

Received Mar 14, 2024 · Event occurred May 1, 2023

Report 3015223097-2024-00001 · MDR key 18901373

Device

Generic name

Cutaneous Electrode Stimulator For Urinary Incontinence

Model number

208

Catalog number

0208-5036

Lot number

2200008BO

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Insufficient Device Problem Information
  • Adverse Event Without Identified Device or Use Problem
  • Insufficient Device Problem Information

Patient

NA · Female

  • Transient Ischemic Attack
  • Insufficient Information
  • Transient Ischemic Attack
  • Insufficient Information

Narrative

Description of Event or Problem

IN MAY 2023 THE CUSTOMER EXPERIENCED TIA (TRANSIENT ISCHEMIC ATTACK). IT IS UNKNOWN AT THIS POINT IN TIME IF THE CUSTOMER EXPERIENCED THE TIA DURING TREATMENT. CUSTOMER SERVICE REPRESENTATIVE ADVISED THE CUSTOMER TO CEASE USE OF THE DEVICE IMMEDIATELY. CUSTOMER PROVIDED A PHYSICIAN LETTER CONFIRMING THE CUSTOMER IS CONTRAINDICATED DUE TO PRE EXISTING MEDICAL PROBLEMS THAT EXISTED BEFORE PURCHASE OF THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO AID WITH THE INVESTIGATION AND ANY INFORMATION RECEIVED WILL BE INCLUDED IN THE FOLLOW UP REPORT.

Description of Event or Problem

FINAL REPORT SUBMITTED - RETURN DEVICE EVALUATION. IN (B)(6) 2023 THE CUSTOMER EXPERIENCED TIA (TRANSIENT ISCHEMIC ATTACK). IT IS UNKNOWN AT THIS POINT IN TIME IF THE CUSTOMER EXPERIENCED THE TIA DURING TREATMENT. CUSTOMER SERVICE REPRESENTATIVE ADVISED THE CUSTOMER TO CEASE USE OF THE DEVICE IMMEDIATELY. CUSTOMER PROVIDED A PHYSICIAN LETTER CONFIRMING THE CUSTOMER IS CONTRAINDICATED DUE TO PRE EXISTING MEDICAL PROBLEMS THAT EXISTED BEFORE PURCHASE OF THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO AID WITH THE INVESTIGATION AND ANY INFORMATION RECEIVED WILL BE INCLUDED IN THE FOLLOW UP REPORT. FINAL REPORT COMMENTS: CUSTOMER WAS CONTACTED BY THE CUSTOMER CARE TEAM ON (B)(6) 2024 AND (B)(6) 2024 REQUESTING ADDTIONAL INFORMATION TO AID THE INVESTIGATION HOWEVER NO RESPONSE HAS BEEN RECEIVED AS OF (B)(6) 2024. THE INNOVO SHORTS AND CONTROLLER WERE RETURNED TO GALWAY, IRELAND ON THE 27TH MAR 2024 AND INSPECTED FOR DEFECTS. THE INNOVO SHORTS PASSED VISUAL INSPECTION. THE CONTROLLER WAS ASSESSED AND IT WAS OBSERVED THAT NO TREATMENT SESSIONS WERE RECORDED, THEREFORE THE SHORTS AND DEVICE WERE NOT USED BY THE CUSTOMER. THE ADVERSE EVENT REPORTED BY THE CUSTOMER IS NOT RELATED TO THE USE OF THE INNOVO DEVICE.

Additional Manufacturer Narrative

BASED ON THE INVESTIGATION OF THE RETURNED DEVICE, THE CONTROLLER WAS ASSESSED AND IT WAS OBSERVED THAT NO TREATMENT SESSIONS WERE RECORDED, THEREFORE THE SHORTS AND DEVICE WERE NOT USED BY THE CUSTOMER. THE ADVERSE EVENT REPORTED BY THE CUSTOMER IS NOT RELATED TO THE USE OF THE INNOVO DEVICE.