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

Model Number 106

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

Patient Problems Unspecified Infection (1930); Seizures (2063); Twiddlers Syndrome (2114)

Event Date 09/19/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Information was received which indicates that the patient had their generator explanted due to an infection that was believed to have been caused by either the patient picking at the incision site or drooling on the incision site.The patient was then explanted and the leads were cut.The device history record was reviewed for both the patient's lead and generator.The generator was sterilized prior to leaving the facility and had a sterilization expiration date of 03/22/2018.The lead was sterilized prior to leaving the facility and had a sterilization expiration date of 10/01/2004.The explanted devices were disposed of by the explanting facility.No return is expected.No other relevant information has been received to date.

Event Description

Information was received from the physician indicating that the patient presented on (b)(6) 2016 with infection and dehiscence wound.The patient's generator was subsequently removed on the same day.No other relevant information has been received.

Manufacturer Narrative

Date of event, corrected data: supplemental mdr #1 inadvertently reported an inaccurate event date.The infection likely began prior to when the physician first noticed it in clinic.Therefore the date of implant is a more appropriate event date.Describe event or problem, corrected data: initial and supplemental #1 mdr inadvertently left off the increase in seizures the patient experienced following a settings change.Relevant tests/laboratory data, including dates, corrected data: initial and supplemental #1 mdr inadvertently left off the settings from (b)(6) 2016.

Event Description

The patient's caretaker reported that the patient experienced an increase in seizures following a settings change on (b)(6) 2016.The seizure log with the neurologist indicated that the patient had one 2 minute seizure on (b)(6) 2016.The patient's settings were then adjusted on (b)(6) 2016.Shortly after the patient became ill which may have contributed to the increase in seizures.

• 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: 6175461
• MDR Text Key: 62541976
• Report Number: 1644487-2016-02797
• 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,Followup,Followup
• Report Date: 02/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/22/2018
• Device Model Number: 106
• Device Lot Number: 203778
• 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: 05/03/2016
• 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: 35 YR