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

Model Number 300-20

Device Problem Battery Problem: High Impedance (2947)

Patient Problem No Information (3190)

Event Date 10/06/2014

Event Type  malfunction  

Event Description

It was reported that the vns patient¿s device was tested and system diagnostic results revealed high impedance (dc dc ¿ 6).The patient was sent for x-rays.No known surgical interventions have occurred to date.

Event Description

Analysis of the lead was completed on 12/15/2014.Scanning electron microscopy images of the positive coil exposed portion show that the coil was exposed to some type-of electro-cautery tool.Scanning electron microscopy images of the negative coil ends at the first and second portion of the lead show that the coil was exposed to and cut using some type of electro-cautery tool as indicated by the fused wires.Review of the 'as-received' photograph taken prior to decontamination shows the lead connectors reversed with the marked connector inserted in the negative terminal/cavity of the pulse generator and the unmarked connector inserted in the positive terminal/cavity of the pulse generator header.Note that since a portion of the lead (including the electrode helices) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.Analysis of the generator was completed on 12/16/2014.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.No performance or any other type of adverse conditions were found with the pulse generator.

Event Description

It was reported that the patient underwent generator replacement due to lead discontinuity.The explanted generator and lead were received for analysis.Analysis is underway, but has not been completed to date.

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: 4221731
• MDR Text Key: 4970355
• Report Number: 1644487-2014-02907
• 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: 10/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/1999
• Device Model Number: 300-20
• Device Lot Number: 3690C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/1996
• 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: 25 YR