MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

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

Patient Problems Muscle Weakness (1967); Dizziness (2194); Ambulation Difficulties (2544)

Event Date 04/16/2021

Event Type  Injury  

Event Description

The patient recently had prophylactic generator replacement and was set to the same settings as before the surgery.Following the surgery, he reported having episodes of falling, like all of a sudden he would lose strength, get light headed, and fall over.It was noted that during the patient's follow-up appointment, the magnet was swiped and the patient fell over as described.They were not sure if the vns was causing the issues but disabled it just in case.They had hypothesized that the patient could be having bradycardic episodes but bradycardia was not confirmed.It was noted by the physician that the patient was experiencing a sudden near faint like feeling that is not seizure-like or associated with postictal symptoms.Per the physician, the cause of the faint-like episodes is due to underlying health condition and worsened by vns.The device was turned back on.No further relevant information has been received to date.

Manufacturer Narrative

H10.Corrected data, initial report: should have used health effect code e1621 for muscle weakness rather than e2302 for ambulation difficulties.

• Brand Name: PULSE GEN MODEL 1000
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 11826259
• MDR Text Key: 250669400
• Report Number: 1644487-2021-00663
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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: 08/09/2021

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: 08/18/2022
• Device Model Number: 1000
• Device Lot Number: 205394
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 04/21/2021
• Initial Date FDA Received: 05/14/2021
• Supplement Dates Manufacturer Received: 08/09/2021
• Supplement Dates FDA Received: 08/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR