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

Model Number 106

Device Problem Protective Measures Problem (3015)

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

Event Date 12/17/2019

Event Type  malfunction  

Event Description

The patient had prophylactic generator replacement, and the explanted generator was returned.Generator analysis was completed.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications except for the backup capacitor to can measurements.When an external 4.0 nf capacitor was connected between the generator case and positive output, comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.This confirmed that the positive feed-thru capacitor was electrically open.A visual assessment of the pcba found contaminates on the trimmed edge of pcba.When the positive feed-thru wire of the assembly was manipulated the capacitance value was variable and would periodically measure as an electrical open.The most probable cause of the error with the backup capacitor to can test was identified to be an open capacitor, separation of the silver polyimide.It was noted that manipulation of the feed-thru wires may have been a contributing factor.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: 9990404
• MDR Text Key: 190125611
• Report Number: 1644487-2020-00637
• 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: 04/23/2020

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: 06/15/2019
• Device Model Number: 106
• Device Lot Number: 5375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Event Location: Other
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• 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: 21 YR