MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Swelling (2091); Discomfort (2330)

Event Date 05/01/2015

Event Type  Injury  

Manufacturer Narrative

Event Description

On (b)(6) 2015 it was reported that the patient's generator migrated into the lower ribcage area and the patient was complaining of tightness in the neck.Diagnostics were good.Clinic notes were received on (b)(6) 2015 which indicated the patient is having swelling on the left side of her neck, along the vns leads.It was also noted that the vns generator has a palpable edge that is causing the patient pain.The physician noted that the patient has grown two cup sizes since the vns was implanted.The patient feels that a revision is justified based on her current level of discomfort.The patient underwent a generator pocket revision surgery on (b)(6) 2015.Good faith attempts for further information from the physician were unsuccessful.

Event Description

The physician confirmed that a non-absorbable suture was used to secure the generator during implant.

• Brand Name: PULSE GEN MODEL 105
• 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: 5072957
• MDR Text Key: 25620096
• Report Number: 1644487-2015-05753
• 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: Health Professional
• Type of Report: Initial
• Report Date: 08/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/18/2016
• Device Model Number: 105
• Device Lot Number: 203064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/18/2015
• Initial Date FDA Received: 09/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2014
• 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: 17 YR