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 06/05/2019

Event Type  malfunction  

Event Description

Initial report was that a physician was inquiring about whether or not the patient¿s device had prematurely depleted.The device history record of the generator was reviewed, and it was confirmed that the device was laser-routed during the manufacturing process.Internal investigation showed that the observed premature battery life indicators were predominately caused by conductive debris from the laser-routing process resulting in leakage paths.Data from the patient's device was reviewed and it confirms that the battery depleted more quickly than expected.Clinic notes were received for the patient.Clinic notes indicated that the vns battery had dropped significantly since the patient¿s last office visit.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

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

Manufacturer Narrative

Corrected data, report no.1: device returned date inadvertently not included.

Event Description

Generator product analysis was completed.A visual assessment on the pcba, performed at the product analysis test bench, showed contaminates on the trimmed edge of the pcba (tab removed).No other visual anomalies were identified.The product analysis lab confirmed an ifi (intensified follow-up indicator)=no condition.Based on 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.Remaining residual material on the pcba edge after the ¿test tab¿ removal manufacturing process resulted in increased current consumption (out of speciation) for both standby and pulsing modes of operation, and may have been the contributing factor for the reported allegation of premature end of life.

• 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: 8744926
• MDR Text Key: 149529133
• Report Number: 1644487-2019-01238
• 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: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/05/2017
• Device Model Number: 106
• Device Lot Number: 203469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/05/2019
• Initial Date FDA Received: 06/28/2019
• Supplement Dates Manufacturer Received: 08/07/2019; 09/11/2019
• Supplement Dates FDA Received: 08/29/2019; 09/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2015
• 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: 30 YR