MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem No Display/Image (1183)

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

Event Date 02/20/2020

Event Type  malfunction  

Event Description

The patient underwent prophylactic generator replacement.It was reported that the patient's generator was showing a fluctuating battery status indicator prior to replacement.The generator battery reached an intensified follow-up indicator (ifi) = yes status, and then later, without a settings change, showed an ifi = no condition.Per explanting facility procedures, the explanted generator has been discarded.Data decoder was created and reviewed.Based on the charge consumption and a discrepancy between percent battery charge remaining (pbcr) estimates using the charge consumption history versus the measured battery voltage, it was determined that the generator was not expected to be at ifi = yes.No obvious cause for the fluctuating ifi = yes status was found in the data decoder.An internal investigation indicated that this fluctuating ifi = yes battery status is likely the result of a transient short circuit involving the generator battery, or a random component failure.A review of device history records for the generator showed that no unresolved non-conformances were found, and the generator passed all quality control measures prior to distribution.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• 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: 9849527
• MDR Text Key: 187949989
• Report Number: 1644487-2020-00466
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750030
• UDI-Public: 05425025750030
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2020

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: 05/15/2017
• Device Model Number: 103
• Device Lot Number: 203402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 03/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2015
• 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: 13 YR