MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

Model Number 302-20

Device Problems High impedance (1291); Improper or Incorrect Procedure or Method (2017); Battery Problem (2885)

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

Event Date 04/02/2013

Event Type  malfunction  

Event Description

It was reported that the vns patient underwent generator replacement surgery due to battery depletion on (b)(6) 2014.During the procedure, diagnostic results with the replacement generator and the existing lead revealed high lead impedance (lead impedance - high).The device was not programmed on following surgery.A local partner mentioned that surgeon did not follow the manufacturer's recommendations during the replacement procedure.No known interventions have occurred to date.Review of the available programming and diagnostic history showed that high lead impedance was observed on (b)(6) 2013.Diagnostics through (b)(6) 2012 were within normal limits.Review of manufacturing records for the lead confirmed all quality tests were passed prior to distribution.

Event Description

Additional information was received stating that the explanting facility likely discarded the explanted generator; therefore, no analysis can be performed on the generator.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records for the lead confirmed all quality tests were passed prior to distribution.Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description

It was reported that no surgical intervention has occurred to date.No known trauma occurred that is believed to have cause the high impedance.

Manufacturer Narrative

Evaluation codes; the previously submitted mdr inadvertently provided the wrong evaluation codes.

Event Description

It was reported that vns patient underwent lead replacement on (b)(6) 2014 due to the high impedance.The explanting facility discarded the explanted device; therefore, no analysis can be performed.

• Brand Name: LEAD MODEL 302
• 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: 3702523
• MDR Text Key: 4330876
• Report Number: 1644487-2014-00772
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor,company represent
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/25/2014

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: 12/31/2006
• Device Model Number: 302-20
• Device Lot Number: 11652
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 06/05/2014
• Initial Date FDA Received: 03/26/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 05/20/2014; 07/01/2014; 11/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2004
• 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: 24 YR