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

Model Number	102R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	06/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation is not necessary because the reported event has been determined as not related to vns therapy.
Event or Problem Description
Patient experienced generator migration which caused discomfort and was referred to surgery to have a generator replacement their device explanted.No known surgical intervention has occurred to date.No other relevant information has been received to date.
Event or Problem Description
The patient underwent surgery to have their vns device removed.The explanted generator and lead were received and product analysis is still underway.
Event or Problem Description
Product analysis was conducted on the explanted generator.In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.There were no performance, or any other type of adverse condition found with the pulse generator.Product analysis is still underway for the lead.
Event or Problem Description
Product analysis was conducted on the explanted lead.Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.With the exception of the observed tear at electrode bifurcation split area, and the surface cut at bifurcated tube, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.Based on the findings in the product analysis lab, there are no anomalies identified with the returned portions of the device.
Additional Manufacturer Narrative
H3 device evaluated by mfr? , corrected data: follow-up report #2 inadvertently left blank.H6 adverse event problem codes, corrected data: follow-up report #2 inadvertently left blank.

• Brand Name: PULSE GEN MODEL 102R
• Common Device Name: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 10836925
• Report Number: 1644487-2020-01520
• Device Sequence Number: 17076790
• Product Code: LYJ
• UDI-Device Identifier: 05425025750023
• UDI-Public: 05425025750023
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/06/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/15/2017
• Device Model Number: 102R
• Device Lot Number: 4410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Event Location: Other
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 01/26/2021; 03/03/2021; 04/13/2021
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 02/19/2021; 03/26/2021; 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR