MAUDE Adverse Event Report: ACTEGY LTD REVITIVE ARTHRITIS KNEE; CIRCULATION BOOSTER

Model Number REVITIVE ARTHRITIS KNEE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Arrest (1762)

Event Date 08/21/2018

Event Type  Injury  

Event Description

A female customer ((b)(6)) used the device on tuesday (b)(6) 2018 in the morning and began to feel chest pains on tuesday evening.She went to the doctors on wednesday morning and the doctor called an ambulance for her to go to (b)(6) hospital in (b)(6).They confirmed that she had a heart attack and did an angiogram.The hospital confirmed that (b)(6) had a heart attack.Subsequently after leaving hospital the customer suffered another heart attack on (b)(6) 2018.Customer questionnaire completed over the telephone with the help of her daughter ((b)(6)) on (b)(6) 2018.Device returned to actegy ltd and tested on 1 october 2018 and tested.

• Brand Name: REVITIVE ARTHRITIS KNEE
• Type of Device: CIRCULATION BOOSTER
• Manufacturer (Section D): ACTEGY LTD; reflex, cain road; bracknell, berkshire RG12 1HL; UK RG12 1HL
• Manufacturer (Section G): MIRAE MEDI AND TECH CO., LTD; 22 baeksuk-dong 5-gil; seobuk-gu; cheonan city, ; KS
• Manufacturer Contact: lawrence brookfield ; reflex, cain road; bracknell, berkshire RG12 -1HL ; UK RG12 1HL
• MDR Report Key: 7937855
• MDR Text Key: 122800759
• Report Number: 3010078417-2018-00009
• Device Sequence Number: 1
• Product Code: NGX
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: REVITIVE ARTHRITIS KNEE
• Device Catalogue Number: 2836AA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Device Age: 1 YR
• Initial Date Manufacturer Received: 09/19/2018
• Initial Date FDA Received: 10/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 81 YR
• Patient Weight: 71