MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problems Under-Sensing (1661); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/12/2016

Event Type  malfunction  

Event Description

It was reported that the patient's generator was unable to detect a heart rate in the chest pocket on the date of implant surgery.A company representative performed some trouble-shooting during the heartbeat verification process.The output current of the generator was turned off during trouble-shooting.Only the least sensitive sensitivity level was used during trouble-shooting.A pre-operative evaluation was not performed prior to surgery in order to determine the patient's candidacy for the tachycardia detection feature of the generator.Review of the generator device history records confirmed that all quality specifications were met prior to distribution.No additional relevant information has been received to date.No known surgical intervention has occurred to date.

Manufacturer Narrative

Device evaluation is not necessary as the reported issue was determined to be due to settings and not a malfunction.

Event Description

It was reported that after the patient's heartbeat sensitivity was increased from 1 to 5, the patient's heart rate was able to be detected successfully.Review of the generator's internal data verified the generator's sensing function.After the seizure sensitivity was adjusted, 30 seizures were detected within 7 days.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6225026
• MDR Text Key: 63955863
• Report Number: 1644487-2017-02982
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/02/2018
• Device Model Number: 106
• Device Lot Number: 203894
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/17/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/24/2016
• 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: 47 YR