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

Model Number 106

Device Problems Migration or Expulsion of Device (1395); Unintended Movement (3026)

Patient Problem Pain (1994)

Event Date 10/17/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the patient underwent surgery due to generator migration, which was causing the patient some pain, on (b)(6) 2016.It was noted the surgeon placed the generator inside an anti-bacterial pouch to hold it in place.It was reported the generator no longer moved around.It was explained the anti-bacterial pouch was placed to stabilize the device and there was no sign of drainage or infection.Attempts for additional relevant information from the physicians have been unsuccessful to date.

Manufacturer Narrative

This information was inadvertently reported incorrectly on the initial mfr.Report.

Event Description

The surgeon further clarified that he did use non-absorbable suture during the patient's first implant surgery to anchor the generator.The surgeon also explained that during the repositioning surgery he put the generator in a sterile pouch and used multiple areas on the pouch to anchor the generator and keep it from continually flipping.It was noted this was done for patient comfort, it was done because he was worried the constant rubbing of the generator may cause dehiscence, and because the constant flipping may cause the lead to coil up and possibly dislodge from the vagus nerve.

• 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: 6181480
• MDR Text Key: 62597029
• Report Number: 1644487-2016-02896
• 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: 01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/13/2018
• Device Model Number: 106
• Device Lot Number: 203833
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2016
• 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): Required Intervention
• Patient Age: 27 YR