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

Model Number 105

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

Patient Problems Unspecified Infection (1930); Twiddlers Syndrome (2114)

Event Date 01/28/2015

Event Type  Injury  

Event Description

It was reported that the vns patient was picking at the generator site and opened the wound, causing infections to develop at the generator and electrode sites.The patient underwent surgery on (b)(6) 2015 to explant the device.The patient has not been re-implanted to date.Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Manufacturer Narrative

This information was inadvertently left off of previous mfr.Report: suspect device udi: (b)(4).

• Brand Name: PULSE GEN MODEL 105
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4553967
• MDR Text Key: 5460098
• Report Number: 1644487-2015-03997
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/03/2015

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: 11/30/2016
• Device Model Number: 105
• Device Lot Number: 203181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/07/2015
• Initial Date FDA Received: 02/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2014
• 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: 16 YR