MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 104; GENERATOR

Model Number 104

Device Problem Computer Operating System Problem (2898)

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

Event Type  malfunction  

Event Description

The patient's generator was replaced due to battery depletion and was subsequently received for analysis.Product analysis of the generator found that the device had reached an end-of-service status as a result of normal battery depletion.It was also found that the internal crystal was not oscillating.The crystal was removed and replaced, and after replacement the device performed according to functional specifications.Of note, the generator was received in one box containing multiple pulse generators, which could have been a contributing factor.The exact failure mechanism for the crystal was not ascertained from product analysis.No additional or relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 104
• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7817176
• MDR Text Key: 118255697
• Report Number: 1644487-2018-01498
• Device Sequence Number: 1
• Product Code: LYJ
• 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: 08/26/2018

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: 03/31/2016
• Device Model Number: 104
• Device Lot Number: 3927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Event Location: Other
• Initial Date Manufacturer Received: 07/31/2018
• Initial Date FDA Received: 08/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2014
• 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