MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

Model Number 304-20

Device Problem High impedance (1291)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/12/2016

Event Type  malfunction  

Manufacturer Narrative

Event Description

It was reported that during a routine office visit the physician found high impedance.Diagnostics were run on this patient 4 months earlier and high impedance was not seen during that visit.X-rays were performed and no gross fractures were observed.No trauma or contributory factors were reported to have caused the high impedance.The patient's generator was programmed off.Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution.No known surgical interventions have been performed to date.Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description

The patient underwent a generator and lead replacement.During surgery, the surgeon observed a small kink in the lead which caused a small hole in the lead which allowed fluid to enter.The explanted lead and generator have not been received to date.

Event Description

It was reported that the explanted lead and generator will not be returned.Therefore product analysis will not be performed.

• Brand Name: LEAD MODEL 304
• 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: 5636870
• MDR Text Key: 45635557
• Report Number: 1644487-2016-00965
• 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,Followup
• Report Date: 04/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2018
• Device Model Number: 304-20
• Device Lot Number: 3899
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2014
• 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: 10 YR