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

Model Number 102

Device Problem Insufficient Information (3190)

Patient Problems Dehydration (1807); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Seizures (2063); Vomiting (2144); No Code Available (3191)

Event Date 07/23/2015

Event Type  Injury  

Event Description

It was reported that the patient's device was programmed on initially on wednesday (b)(6) 2015.On (b)(6) 2015, patient experienced nausea, vomiting and seizures.Patient visited the er and was found to have e-lye imbalance as well as low bp with systolic 80.Patient was given if fluids and mg++ and k+ and was sent home.Patient has not had further seizures but had vomiting again.Clinic notes form the er visit indicate that the patient's last seizure prior to vns implant was in (b)(6).Patient experienced two seizures on (b)(6) 2015 and two on (b)(6) 2015.Tests indicate that the patient has slightly elevated creatinine, secondary to dehydration.Patient had received almost two liters of fluid with improvement in her blood pressure.On (b)(6) 2015, it was stated that the patient is feeling better.Attempts for additional relevant information were unsuccessful to date.

Manufacturer Narrative

Suspect device udi: (b)(4).Additional manufacturer narrative and/or corrected data, corrected data: suspect device udi: (b)(4).The suspect device udi was inadvertently not provided in the initial mdr.

Manufacturer Narrative

Supplemental report #1 inadvertently does not state the aware date.The aware date of the previous mdr is (b)(4) 2015.

• Brand Name: PULSE GEN MODEL 102
• 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: 5016968
• MDR Text Key: 23522875
• Report Number: 1644487-2015-05556
• 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,consum
• Reporter Occupation: Physician
• Report Date: 07/27/2015

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: 01/14/2017
• Device Model Number: 102
• Device Lot Number: 203260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2015
• 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: 61 YR