MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Premature End-of-Life Indicator (1480)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/20/2019

Event Type  malfunction  

Event Description

Initial report was that a patient was at ifi (intensified follow-up indicator) yes and the physician felt that the device had prematurely depleted.Clinic notes were received for the patient and indicated that the generator was nearly depleted resulting in the physician referring the patient for generator replacement.The device history records for the generator were reviewed and show that no unresolved non-conformance's were found.The device met all specifications for release prior to distribution and was manufactured with a laser routing process.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Manufacturer Narrative

Corrected data, supplemental report 1: explant date inadvertently not included.

Event Description

Generator product analysis was completed.The product analysis lab confirmed that the generator was at ifi (intensified follow-up indicator)=yes condition and that the device had prematurely depleted.A visual assessment on the pcba, performed at the pa test bench, showed contaminates on the trimmed edge of the pcba (tab removed).No other visual anomalies were identified.The contamination that was observed on the trimmed edge of the pcba suggest probable electrical paths (resistive path) were established between the copper edges on the trimmed edge of the pcba, which contributed to the supply current conditions.There were no other performance of any other type of adverse events found with the pulse generator.

Event Description

Patient underwent generator replacement.The explanted generator was received by product analysis.Product analysis has not been completed to date.

• Brand Name: PULSE GEN MODEL 106
• 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: 8505849
• MDR Text Key: 141768027
• Report Number: 1644487-2019-00696
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/14/2017
• Device Model Number: 106
• Device Lot Number: 203806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2016
• 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 Age: 34 YR