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

Model Number 105

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 08/11/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

A physician reported to an international distributor that at a patient developed an infection at the implant site roughly 2 months after vns replacement surgery.The physician is unsure of the cause of the infection but suspects a titanium allergy.The patient experienced no prior allergies, infections, reactions with his prior vns device.The physician elected to remove the pulse generator.Manufacturing records were reviewed for the patient's pulse generator and lead and proper sterilization was verified for each prior to product distribution.The explanted generator was discarded by the explanting facility and is therefore unable to be returned to the manufacturer for product analysis.

Manufacturer Narrative

Uchida, d & yamamoto, t.(2017).Experience and solution of complications of vagus nerve stimulation therapy in 139 implant patients.No shinkei geka, 45(12):1051-1057.Doi: 10.11477/mf.1436203646.

Event Description

An abstract from a research article comprised of post-market surveillance data from a hospital¿s vns patients implanted between december 2010 and march 2016 was (also) received.The abstract indicated that four patients experienced recurrent vocal cord paralysis.The abstract also indicated that one patient experienced subsequent aspiration pneumonia.Three patients underwent explant due to surgical site infections, and one patient underwent explant due to a patient-influenced revolving of the generator which eventually resulted in lead fracture.The recurrent vocal cord paralysis is reported within mfr.Report # 1644487-2018-00123.A company representative received identifying patient information from the authoring physicians of the article for the patients who experienced surgical-site infections and generator migration and subsequent lead fracture, originally captured in mfr.Report #1644487-2018-00122.It was determined that the infections were previously reported to the manufacturer and are captured in mfr.Report #s 1644487-2013-02562, 1644487-2013-03225, and 1644487-2015-06368, the last of which corresponds to the events captured within this report.Per the abstract, allergic reaction was suspected to be a cause of the infection captured in this report.The reported patient-influenced migration and subsequent lead fracture was previously reported to the manufacturer and is captured within mfr.Report # 1644487-2018-00289.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: 5218034
• MDR Text Key: 30995831
• Report Number: 1644487-2015-06368
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/23/2017
• Device Model Number: 105
• Device Lot Number: 203316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2015
• 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: 29 YR