MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problems High impedance (1291); Poor Quality Image (1408)

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

Event Date 08/08/2014

Event Type  malfunction  

Event Description

X-rays were provided to the manufacturer for further review.Generator placement could not be assessed as a chest x-ray image was not provided.Lead pin insertion cannot be assessed due to the poor pixel resolution of the images provided.The filter feed-through wires appear to be intact.Part of the lead was behind the generator and could not be assessed.No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed.Additional information was received stating that the vns patient underwent lead replacement surgery on (b)(6) 2015 due to lead discontinuity.The explanted lead has been returned to the manufacturer where analysis is currently underway.

Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device.X-rays reviewed by manufacturer, no gross lead discontinuities visualized.Describe event or problem; corrected data: the previously submitted mdr inadvertently stated the x-ray images could not be assessed due to the quality of images.While a thorough assessment cannot be made, portions of the x-rays could be reviewed.

Event Description

It was reported that the vns patient's device showed high impedance.X-rays were provided but cannot be assessed due to the poor quality of the images.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

Analysis of the returned lead portions was completed.The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time.The marks are evidence of a potentially insufficient mechanical contact between conductive surfaces of the generator and connector ring, resulting in a suspect electrical connection to the lead.Continuity checks of the returned lead portions were performed and no discontinuities were identified.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• 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: 4377881
• MDR Text Key: 5183289
• Report Number: 1644487-2015-03512
• 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: 12/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Model Number: 103
• Device Lot Number: 203017
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/21/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2014
• 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: 5 YR