MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

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

Patient Problems Seizures (2063); Numbness (2415)

Event Date 05/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient is experiencing a burning and numbing sensation up the left side of her neck and face with stimulation.The patient believes this is triggering seizures, although the physician noted that the patient did not demonstrate any seizure-like activity with these symptoms while in office.The pulse width setting was adjusted to try to help with the symptoms, but it was unsuccessful.The device was disabled.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

It was reported that the physician looked at x-rays and did not observe any issues with the lead.X-rays have not been reviewed by the manufacturer to date.The patient's generator was replaced.The explanted generator was discarded per hospital policy.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 10159484
• MDR Text Key: 195300440
• Report Number: 1644487-2020-00813
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750016
• UDI-Public: 05425025750016
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/20/2020

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 Expiration Date: 09/12/2015
• Device Model Number: 102
• Device Lot Number: 3805
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/22/2020
• Initial Date FDA Received: 06/16/2020
• Supplement Dates Manufacturer Received: 06/25/2020
• Supplement Dates FDA Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR