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

Model Number 106

Device Problem No Display/Image (1183)

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

Event Date 06/08/2018

Event Type  malfunction  

Event Description

It was reported that the patient¿s battery indicated 25-50% during a recent interrogation.However, the range was 11-25% previously in the physician's office.The patient's settings were recently lowered, but this was not able to be confirmed as the cause of the fluctuation in the battery status indicator.No further relevant information has been received to date.

Event Description

The data from the two vns tablets involved in the event was reviewed by the manufacturer.The fluctuating battery status indicator was an expected event as the 25% indicator is flagged at 2.87 v for a m106 generator.On 04/19/2018, the battery voltage was at 2.849 v, which is 21 mv below the value at which the 25% indicator is flagged.The diagnostics were within normal limits.Two months later, the battery voltage was at 2.883 v, which is 13 mv above the 25% indicator voltage ceiling.The diagnostics were within normal limits.A rebound of 34 mv within two months was determined to be within reason and is not indicative of a device failure.

• 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: 7659169
• MDR Text Key: 113183427
• Report Number: 1644487-2018-01117
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/18/2018

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: 02/18/2017
• Device Model Number: 106
• Device Lot Number: 203494
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/08/2018
• Initial Date FDA Received: 07/03/2018
• Supplement Dates Manufacturer Received: 09/18/2018
• Supplement Dates FDA Received: 09/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2016
• 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: 17 YR