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

Model Number 302-20

Device Problems Fracture (1260); Low impedance (2285); Low Battery (2584)

Patient Problems Chest Pain (1776); Pain (1994); Depression (2361)

Event Date 10/30/2012

Event Type  malfunction  

Event Description

It was reported that the patient felt a painful event where the generator felt as though it had turned in her chest and since then, the patient has experienced more depressive episodes.The patient feels that the generator battery may be running low.The patient was given a name of a physician to have the device checked.No additional relevant information has been received to date.

Event Description

It was reported that the patient was referred for generator replacement surgery.Review of the referral clinic notes showed a dc-dc code of (b)(4) during the office visits, which was believed to be within normal limits at the time of review.During the replacement surgery, the patient¿s new m103 generator registered low impedance.The patient was reportedly a twiddler, and the surgeon observed that the lead was broken as a result.The lead was also replaced at that time.The explanted lead has not been returned to the manufacturer to date.

Manufacturer Narrative

Follow-up report #2 inadvertently omitted the information that the explanted devices were discarded.(b)(4).

Event Description

The explanted products were reported to have been discarded by the explanting facility.

• 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: 4162145
• MDR Text Key: 4785300
• Report Number: 1644487-2014-02617
• Device Sequence Number: 1
• Product Code: MUZ
• 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: Consumer,Company Representative,company representative
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2008
• Device Model Number: 302-20
• Device Lot Number: 1300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 09/10/2014
• Initial Date FDA Received: 10/10/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 09/13/2016; 01/03/2017; 01/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2005
• 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 Age: 45 YR