MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE M102 VNS; STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY

Model Number M102

Device Problem Computer Software Problem (1112)

Patient Problems Incontinence (1928); Nausea (1970); Vertigo (2134); Choking (2464); Sleep Dysfunction (2517); Convulsion/Seizure (4406); Swelling/ Edema (4577)

Event Date 09/29/2022

Event Type  Injury  

Event Description

Implanted medical device programmer was hacked.Symptoms include seizures, swelling, incontinence, nausea, choking, sleep disruption, vertigo, etc.Fda safety report id# (b)(4).

• Brand Name: PULSE M102 VNS
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
• Manufacturer (Section D): LIVANOVA USA, INC.
• MDR Report Key: 15537135
• MDR Text Key: 301189743
• Report Number: MW5112400
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/29/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M102
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/03/2022
• Patient Sequence Number: 1
• Treatment: KEPRA; MULTI-VITAMINS
• Patient Outcome(s): Disability; Life Threatening; Hospitalization; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American