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

Model Number 304-20

Device Problems Corroded (1131); Fracture (1260); Low impedance (2285)

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

Event Date 08/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that low impedance was detected.No trauma or manipulation of the device was reported.The device was disabled.No surgical intervention has been performed to date.No additional relevant information has been received to date.

Event Description

It was reported that the patient's low impedance was a result of the patient twiddling his lead, which knotted and broke the lead.The patient's lead was replaced due to the low impedance.Suspect product was received.No additional relevant information has been received to date.

Manufacturer Narrative

(b)(4).

Event Description

Product analysis was completed on the returned lead.The majority of the lead body was returned but not the electrode array.Visual analysis noted several abrasions along the outer tubing as well tearing on the portion of the lead near the pin.The lead body was twisted near the lead pin and the lead appeared compressed in several locations.Setscrew marks on the connector pin indicated that there was a good mechanical and electrical connection between the lead and generator at one time.Two coil breaks were noted at the end of lead body.Microscopic analysis identified pitting on the fractured end of the lead.Both the positive and negative lead fractures were attributed to mechanical stress.The appearance fracture at the negative lead coil suggested that it fractured due to rotational mechanical stress in at least two of the three strands.Low impedance was not replicated during product analysis.No other anomalies were found.No further relevant information has been received to date.

• 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: 5949291
• MDR Text Key: 55053866
• Report Number: 1644487-2016-02061
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2017

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: 12/17/2019
• Device Model Number: 304-20
• Device Lot Number: 4668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/22/2016
• Initial Date FDA Received: 09/14/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/15/2016; 01/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2016
• 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: 61 YR