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

Model Number 105

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Unspecified Infection (1930); Pain (1994); Pocket Erosion (2013); Weight Changes (2607)

Event Date 11/12/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient had an infection at the generator pocket following generator and lead implant surgery.A review of manufacturing records indicated that both the lead and generator were sterilized prior to distribution.Two weeks after the implant surgery the patient underwent a pocket washout and re-suturing procedure.The infection resolved however over time the scar at the generator incision widened and thinned.The physician believed this was related to the infection and washout procedure.Additionally, the patient began antidepressant therapy which caused weight loss which also contributed to the thinning of the scar.Eventually the scar thinned to the point that the vns generator was protruding.It was reported that the patient experienced pain during activities where the generator site was being rubbed such as when getting out of a pool.The patient was then referred for scar revision surgery to address the protruding generator.However the scar revision surgery is not known to have occurred to date.

Event Description

It was reported that the patient underwent scar revision surgery; however, the surgeon did not replace the generator during the surgery.No additional relevant information has been received to date.

• 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: 5913612
• MDR Text Key: 53476287
• Report Number: 1644487-2016-01953
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/08/2016
• Device Model Number: 105
• Device Lot Number: 4033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2014
• 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: 7 YR