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

Model Number 302-20

Device Problems Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 07/25/2017

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr? na.Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.

Event Description

It was reported that the patient was going for a vns explant due to the device being uncomfortable for patient and not working.Per a battery life calculation, the device would have reached eos prior to 2010.Therefore the device not working is likely due to battery depletion.The nurse mentioned that the patient had the surgery due to discomfort.Information regarding location of the discomfort and the onset of pain is unknown.The nurse mentioned that the surgery was done because patient requested it.Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.

Event Description

Further information was received that the lead was also explanted when the generator was explanted.No further relevant information has been received to date.

Manufacturer Narrative

The initial mdr indicated that device evaluation was not necessary as reported event(s) were not related to the functionality or delivery of therapy of the device.After the lead was returned and analyzed, a malfunction was found.This lead malfunction may have contributed the reported event as the cause of the reported event was not determined.Therefore, adverse event or product problem, corrected data: follow-up report #1 inadvertently did not include product problem suspect medical device, corrected data: follow-up report #1 inadvertently did not change the suspect device to the lead from the generator.Device code-event problem codes , corrected data: follow-up report #1 inadvertently did not include 1250, fluid leaks as a code.Type of reportable event, corrected data: follow-up report #1 inadvertently did not select 'malfunction' if follow-up what type?, corrected data: follow-up report #1 inadvertently did not select "device evaluation" device evaluated by mfr?, corrected data: follow-up report #1 inadvertently did not select "yes".

Event Description

Further information was received that product analysis was completed on the generator.Other than typical explant procedure related observations, no surface abnormalities were noted on the generator.An open can measurement of the battery voltage determined that the battery was depleted.The generator was unable to be interrogated due to this depleted battery condition.The generator performed according to functional specifications.Product analysis was also completed on the returned lead.A section of the lead assembly was returned for analysis in one piece, but the lead's electrodes were not returned for evaluation.Set screw marks were seen on the connector pin providing evidence that proper contact between the set screw and the connector pin existed at least once.Abrasions were noted on the connector boot.Abrasions were noted on the outer silicone tubing at multiple locations.The outer silicone tubing had a compressed appearance at multiple locations.The outer silicone tubing had what appeared to be internal abrasions at multiple locations.Abrasions most likely caused by the presence of a tie-down were noted.The inner silicone tubing of the lead coils is abraded open.The lead assembly had dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing.No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portion.No anomalies or discontinuities were found.An evaluation could not be made on the portion that was not returned.No further relevant information has been received to date.

• 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: 6820093
• MDR Text Key: 83629635
• Report Number: 1644487-2017-04360
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2004
• Device Model Number: 302-20
• Device Lot Number: 9502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2002
• 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 Outcome(s): Required Intervention
• Patient Age: 23 YR