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

Model Number 106

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

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

Event Date 08/18/2015

Event Type  malfunction  

Event Description

It was reported that the patient's generator was replaced prophylactically.The generator was returned and underwent product analysis where evidence of premature battery depletion was found.Upon opening the generator can, visual analysis identified contaminates on the trimmed edge of the printed circuit board assembly (pcba).The post burn electrical test indicated that the contamination on the trimmed edge of the pcba was suggestive of probable electrical paths that were established between the copper edges, which could contribute to premature battery depletion.No further anomalies were identified with the generator outside of the contaminates and premature battery depletion and the generator performed according to functional specifications.The device history record of the generator were reviewed and indicated that the generator passed functional specifications prior to distribution, and it was confirmed that the device was laser-routed during the manufacturing process.No further 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: 8762960
• MDR Text Key: 150144280
• Report Number: 1644487-2019-01286
• 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: 07/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/07/2017
• Device Model Number: 106
• Device Lot Number: 203481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Event Location: Other
• Date Manufacturer Received: 06/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2015
• 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: 42 YR