MAUDE Adverse Event Report: BIOTRONIK, INC. ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number ACTICOR 7 VR-T DX

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Protective Measures Problem (3015)

Patient Problems Dizziness (2194); Shock from Patient Lead(s) (3162)

Event Date 04/04/2023

Event Type  malfunction  

Event Description

This patient came into the emergency department with a complaint that he was shocked 3 times by his icd.The concerning issue of this report has more to do with this patient while on a gurney was in a position where he nearly fell off.In an attempt to avoid a fall, a staff member named (b)(6) sirois, grabbed the patient with both of her hands to position him back onto the gurney.At some point during the attempt to get him back on the gurney, his internal icd sent a shock which (b)(6) felt.She felt dizzy and light headed after the shock.She has also been seen by employee health and as of a week ago, still had some symptoms.This report is for both the pt and the staff member.Ref report: mw5117166.

• Brand Name: ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BIOTRONIK, INC.
• MDR Report Key: 16845253
• MDR Text Key: 314302898
• Report Number: MW5117165
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ACTICOR 7 VR-T DX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25 YR
• Patient Sex: Male