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

Model Number 102R

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

Patient Problems Muscle Spasm(s) (1966); Neck Pain (2433)

Event Date 08/04/2020

Event Type  Injury  

Event Description

Clinic notes mention that the patient occasionally feels a ¿pop¿ in the lead for her vns.Notes mention these have not occurred when she is having seizures.Notes mention that vns appears to be functioning well.To clarify the report of ¿pop¿ in the lead, it was indicated that it is painful stimulation.The doctor thinks the device battery is low and giving intermittent therapy.Intervention is that she¿s been referred for replacement.No known surgical intervention has occurred to date.

Event Description

Information was received that the referral for surgery was for patient comfort only as the patient needed a battery replacement.The location of the painful stim was clarified to be at the neck site along the lead.Information was also received that the patient's generator was replaced due to muscle spasms at generator site.The explanted device has not been received for analysis to date.

Event Description

The generator was received for analysis.Analysis is underway but has not been completed to date.

Manufacturer Narrative

B5.Describe event and d10.Device available for evaluation? h3.Device evaluated by mfr; corrected data; supplemental mdr #1 inadvertently omitted disposition of device.

Event Description

Product analysis for the generator was completed and approved.The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment.The pulse generator diagnostics were as expected for the programmed parameters.Analysis concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.

• Brand Name: PULSE GEN MODEL 102R
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 10569522
• MDR Text Key: 208011456
• Report Number: 1644487-2020-01278
• Device Sequence Number: 1
• Product Code: LYJ
• 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,Followup,Followup
• Report Date: 12/07/2020

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: 05/03/2012
• Device Model Number: 102R
• Device Lot Number: 2703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Event Location: Other
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 09/22/2020
• Supplement Dates Manufacturer Received: 10/05/2020; 11/02/2020; 11/30/2020
• Supplement Dates FDA Received: 10/30/2020; 11/24/2020; 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR