MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL UNKNOWN; GENERATOR

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 01/01/2007

Event Type  malfunction  

Event Description

A 3rd party acting on the manufacturer¿s behalf reviewed an internet forum, and it was reported by an anonymous individual that "they implanted a vns but it malfunctioned, shocking me and went to emergency room, a few days later removed." "a doctor who helped with inventing the vns implanted mine, i was in a study.Don't know if it was device or doctor, but it shocked me and knocked me to my knees" "tried vns and it shocked me while i was in pediatrician office (about 12 yrs ago) it knocked me to my knees and was rushed to er.Was told that it was defective, and it was removed a few days later." "vns implanted and removed (device was defective)." no further relevant information has been received to date.

Event Description

The anonymous individual also indicated in comments on an internet forum that "a pace maker runs to your heart.I'm not a fan of vns.It almost killed me while i was at pediatrician with my daughter'." and "i've been on every med and combination of meds.I don't qualify for surgery because i have every type of seizure.When vns first came about the doc who invented it implanted one.I was in a test group.Guess what? the device/ doctor was defective.It was shocking me bringing me to my knees.They removed it and it damaged vagus nerve so i can't try again.Too dangerous and doctors are afraid to try." no further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL UNKNOWN
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8854982
• MDR Text Key: 153091458
• Report Number: 1644487-2019-01487
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 07/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention