MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

Model Number 302-20

Device Problem Fracture (1260)

Patient Problems Dyspnea (1816); Pain (1994)

Event Date 02/01/2017

Event Type  malfunction  

Event Description

It was reported that the patient had been feeling shocks that caused the patient to be unable to talk and barely breathe.The patient experienced such painful shocks that he had to be restrained at the emergency department.The written notes from the physician stated that he thought the "ground pulled off the nerve" without any clarification.The patient had full revision surgery due to the painful stimulation, and the physician later reported that there was an observed lead break during the surgery.However, diagnostics were within normal limits immediately prior to the surgery.The explanted product has not been received to date.

Event Description

The generator was received into analysis.The lead was not received from the explanting hospital.The device performed according to functional specifications.Analysis concluded that no abnormal performance or any other type of adverse condition was found.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• 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: 6551020
• MDR Text Key: 74600499
• Report Number: 1644487-2017-03738
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2008
• Device Model Number: 302-20
• Device Lot Number: 1471
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2005
• 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