MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Respiratory Distress (2045); Seizures (2063); Tingling (2171)

Event Date 01/01/2013

Event Type  Injury  

Event Description

It was reported that the patient is undergoing an explant for vns due to experiencing some pain.Additional information was received that the patient's vns was inactive for the last 6 months.Patient experiences radiating pain in her neck.It was later reported that the patient was also diagnosed with pseudo seizures in (b)(6) 2013 based on video eeg.Vns was turned off a month prior to (b)(6) 2013 due to the sensation that it was shocking patient.In (b)(6) 2015, patient reported that she has been having pain with her vns at the implant site, tingling in her neck and can't breathe despite vns being off.Patient's generator was explanted on (b)(6) 2015.The explanted generator has not been received by the manufacturer.

Event Description

The cause of patient's pain, tingling and difficulty breathing while vns is disabled is unclear.The explanted generator is believed to have been discarded.

Manufacturer Narrative

Date of event, corrected data: (b)(6) 2013.The event date was inadvertently reported as (b)(6) 2014 in the initial report.

• Brand Name: PULSE GEN MODEL 102
• 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: 4887499
• MDR Text Key: 6068337
• Report Number: 1644487-2015-05077
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/09/2015

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: 12/31/2004
• Device Model Number: 102
• Device Lot Number: 7732
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/10/2015
• Initial Date FDA Received: 07/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2003
• 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: 40 YR