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

Model Number 106

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Output below Specifications (3004)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 10/22/2016

Event Type  Injury  

Manufacturer Narrative

Udi of suspect device: (b)(4).

Event Description

It was reported that a patient felt a "pop" around her generator site two weeks prior and then started feeling pain at the generator site.The patient also felt that the generator was moving when she moved her arm, and she felt decreased stimulation.Revision surgery was planned, but no known surgery has occurred to date.No further relevant information has been received to date.

Event Description

The patient was seen by the physician, and diagnostics were all within normal limits indicating that the device was functioning properly.The physician did not know the cause of the migration; however, he knew that the device was flipping underneath the patient's skin.The patient felt the "pop" at her generator when she moved her arm.Clarification was received that the patient was not feeling stimulation when she used her magnet.The physician initially reported that the cause patient not feeling stimulation was likely the patient getting used to vns therapy.The physician later reported that he believed that the patient not feeling stimulation was due to a device malfunction; however, device functionality was confirmed via diagnostics.Therefore, the physician was most likely basing his assessment on the patient's clinical symptoms and not the actual functionality of the device.No surgical intervention has occurred to date.

Event Description

The patient had surgery, and the generator was re-secured using a non-absorbable suture.The device was functioning properly after the generator was repositioned.The patient also may have manipulated the device because she was moving the device around in the pocket.

• 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: 6137351
• MDR Text Key: 61188096
• Report Number: 1644487-2016-02757
• 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: 02/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/29/2017
• Device Model Number: 106
• Device Lot Number: 203831
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2016
• 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 Outcome(s): Other
• Patient Age: 23 YR