MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problems Premature End-of-Life Indicator (1480); Under-Sensing (1661); Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 07/14/2015

Event Type  malfunction  

Event Description

The generator was explanted and returned due to prophylactic replacement.No allegations were made against the vns generator.During product analysis, a visual assessment of the printed circuit board assembly (pcba) showed contaminates on the trimmed edge of the pcba.The contamination that was observed on the trimmed edge of the pcba suggested probable resistive electrical paths were established between the copper edges on the trimmed edge of the pcba, which contributed to the supply current and sense settings conditions.Comprehensive electrical testing showed that the generator did not perform according to functional specifications.The results of the final electrical test suggest undersensing from the heart rate sensing feature.The device history record of the generator was reviewed, and it was confirmed that the device was laser-routed during the manufacturing process.The device met all specifications for release prior to distribution.Internal investigation showed that the observed premature battery life indicator and failed heart rate undersensing were predominately caused by conductive debris from the laser-routing process resulting in leakage paths.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 9267361
• MDR Text Key: 164839940
• Report Number: 1644487-2019-02109
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/09/2017
• Device Model Number: 106
• Device Lot Number: 4410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Event Location: Other
• Date Manufacturer Received: 10/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2015
• 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: 43 YR