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

Model Number 106

Device Problem Premature Discharge of Battery (1057)

Patient Problem No Patient Involvement (2645)

Event Date 12/20/2019

Event Type  malfunction  

Event Description

It was reported that the patient was being referred for prophylactic battery replacement.After the replacement, the generator was sent back for product analysis to be performed.Product analysis (pa) was performed on the generator returned.The electrical tests performed in the pa lab found that the generator was at an ifi = no condition.The battery voltage was measured at 2.864 volts, and the memory locations on the generator indicated that 82.618% of the battery had been consumed.Contaminates were visualized on the trimmed edge so the generator was opened.The battery voltage was measured again at 2.904 volts, resulting in an ifi=no condition.The results from the postburn electrical test concluded that the contaminates observed contributed to the supply current conditions.The remaining residual material on the pcba edge after the ¿test tab¿ removal manufacturing process resulted in increased current consumption (out of speciation) for the pulsing mode of operation.The device history records of the generator was reviewed in which it was confirmed that all parameters passed inspection and that the trim test tab was performed which was prior to the manufacturing process being corrected; therefore, the generator of interest is part of the laser routing issue which would cause premature eos.No additional 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: 9581320
• MDR Text Key: 183703678
• Report Number: 1644487-2020-00074
• 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: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• 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: 203476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Event Location: Other
• Date Manufacturer Received: 12/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2015
• 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: 57 YR