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

Model Number 300-20

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

Patient Problem Fall (1848)

Event Date 01/01/2014

Event Type  malfunction  

Event Description

It was reported that device diagnostics resulted in high impedance (dc dc code - 7).The physician programmed the device off after observing the high impedance.The patient was reported to have been doing some heavy lifting with her activities and it was unclear if this was the cause of the high impedance.Further follow-up revealed that no x-rays were performed and the patient was referred to neurosurgeon.The physician reported that the patient suffered a fall onto pavement at school in january or february which may have caused or contributed to the high impedance.No surgical intervention has been performed to date.

Event Description

Additional information was received stating the vns patient¿s generator and lead were replaced due to lead discontinuity.The explanted generator and lead were returned to the manufacturer for analysis.Analysis concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.Monitoring of the device output signal showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.The device performed according to functional specifications.Analysis of the returned lead portion is currently underway.

Event Description

Analysis of the returned lead portion was completed.The lead assembly has 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 portions.Incisions in the silicone tubing were necessary to perform proper inspection of the lead.A break was identified in one of the lead coils.Scanning electron microscopy images of the broken coil shows that pitting or electro¿etching conditions have occurred at the break location.Also, the images of the broken coil strands shows appearance of a stress-induced fracture (fatigue).Note that since the electrode array portion 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 portion.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records of 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.

Manufacturer Narrative

Device failure occurred, but did not cause or contribute to death or serious injury.

Event Description

Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to high impedance.The explanted generator and lead have not been returned to date.

• 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: 3785631
• MDR Text Key: 4360024
• Report Number: 1644487-2014-01174
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/11/2014

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: 03/31/2003
• Device Model Number: 300-20
• Device Lot Number: 2802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/04/2014
• Initial Date FDA Received: 05/01/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 07/21/2014; 08/27/2014; 09/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2001
• 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: 20 YR