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

Model Number 300-20

Device Problem High impedance (1291)

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

Event Date 11/10/2014

Event Type  Malfunction  

Event Description

Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015. The explanting facility discarded the explanted device; therefore, no analysis can be performed.

Event Description

It was reported that the vns patient¿s device showed high impedance (impedance value ¿ 6102 ohms) and an ifi condition during an office visit on (b)(6) 2014. Clinic notes were received indicating that the patient device was working well on (b)(6) 2014. The patient was referred for surgery but no known surgical interventions have occurred to date.

Manufacturer Narrative

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

Event Description

Additional information was received stating that the vns patient had a bad seizure and was subsequently hospitalized. The patient had also been experiencing painful stimulation in the neck region.

• 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: 4318275
• MDR Text Key: 5594607
• Report Number: 1644487-2014-03260
• 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: 11/10/2014

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 12/10/2014
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: LAY USER/PATIENT
• Device EXPIRATION Date: 01/31/2004
• Device MODEL Number: 300-20
• Device LOT Number: 4920
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/23/2015
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 01/09/2002
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 12/10/2014 Patient Sequence Number: 1