MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 01/03/2017

Event Type  Injury  

Event Description

It was reported via clinic notes that the patient experienced painful stimulation at the throat and chest sites with magnet stimulation.She did not feel the pain during normal stimulations.The physician adjusted the magnet mode output current.System diagnostics were within normal limits.The patient's device was at ifi=no, but the physician believed that the battery was low and referred the patient for generator replacement surgery due to the painful stimulation and low battery.The physician reported that the patient did not specify when the painful stimulation started, but she had been having the tolerability issues since the physician started seeing the patient.The physician reported that the surgery was being done due to low battery, as system diagnostics were done and impedance was within normal limits.However, the physician stated that the surgery was also being done to preclude a serious injury.No surgery has occurred to date.

Event Description

The patient had generator replacement surgery due to battery depletion (ifi=yes).The explanted generator has not been received to date.

Event Description

The explant generator was received for analysis on 08/31/2017.Product analysis on was completed and approved on 09/21/2017.The design history record showed that the pulse generator passed all specifications prior to its release.The pulse generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The generator battery showed ifi-yes condition.

• Brand Name: PULSE GEN MODEL 103
• 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: 6727266
• MDR Text Key: 80492207
• Report Number: 1644487-2017-04168
• 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,Followup
• Report Date: 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/02/2015
• Device Model Number: 103
• Device Lot Number: 3546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 59 YR