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

Model Number 106

Device Problem Premature End-of-Life Indicator (1480)

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

Event Date 07/02/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Patient underwent prophylactic generator replacement due to ifi - yes.The explanted device was received and analysis was performed.In the lab, the device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment.The pulse generator showed no signs of variation in the output signal and demonstrated the expected level of output current.The pulse generator diagnostics were as expected for the programmed parameters.The battery, 2.619 volts, shows an ifi=yes condition.The data in the generator memory locations revealed that 67.738% of the battery had been consumed.An ifi=yes condition is not typically observed at 67.738% of battery consumption.With the pulse generator case removed and the battery still attached to the printed circuit board assembly (pcba), the battery measured 2.592 volts confirming an ifi condition.The battery was removed.The pcba was subjected to a postburn electrical test and results show that the pcba failed several electrical tests.Remaining residual material on the pcba edge after the ¿test tab¿ removal manufacturing process resulted in increased current consumption for both standby and pulsing modes of operation, and may have been the contributing factor for the low battery indicator.Internal investigation showed that the observed premature battery life indicators were predominately caused by conductive debris from the laser-routing process resulting in leakage paths.A review of device history records for the generator shows that no unresolved non-conformances were found.

• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6400784
• MDR Text Key: 69817032
• Report Number: 1644487-2017-03368
• 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: 03/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/03/2017
• Device Model Number: 106
• Device Lot Number: 4397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2017
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2015
• 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: 21 YR