MAUDE Adverse Event Report: CYBERONICS, INC. BIPOL LEAD MODEL 300

Model Number 300-20

Device Problems Fracture (1260); High impedance (1291); Unexpected Therapeutic Results (1631)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 11/03/2014

Event Type  malfunction  

Event Description

It was reported that the vns patient was experiencing painful stimulation in her neck.The patient¿s device was tested and system diagnostic results revealed high impedance.The patient¿s device was not subsequently disabled.X-rays were taken and reported to show a gross lead fracture next to a tie-down.The patient was referred for surgery but no known surgical interventions have occurred to date.

Event Description

Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity.The explanted device were returned to the manufacturer for analysis.Analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found.The device performed according to functional specifications.Analysis of the returned lead is currently underway.

Event Description

Analysis of the returned lead portions were completed.The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No other obvious anomalies were noted.Continuity checks of the returned lead portions were performed, and no discontinuities were identified.Note that since the electrode array section was not returned for analysis, an evaluation cannot be made on that portion of the lead.

Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative

Only a portion of the lead was returned for analysis which did not reveal any anomalies.Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

• Brand Name: BIPOL LEAD MODEL 300
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4295204
• MDR Text Key: 5054714
• Report Number: 1644487-2014-03202
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2002
• Device Model Number: 300-20
• Device Lot Number: 845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2000
• 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: 20 YR