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

Model Number 302-20

Device Problems Difficult or Delayed Activation (2577); Human-Device Interface Problem (2949)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271); Chest Tightness/Pressure (2463)

Event Date 04/13/2014

Event Type  Injury  

Event Description

Clinic notes dated (b)(6) 2014 note that the patient was still having symptoms after generator settings changes.It was noted that the patient needs replacement of the lead to see if that will help with her symptoms and allow her to receive full vns therapy.It was noted that no other major changes have occurred in the patient's medical history.An implant card was received indicating that the patient underwent lead replacement on (b)(6) 2014.The explanted device has not been received for analysis to date.

Event Description

It was reported on the implant card that the reason for lead replacement was a ¿lead discontinuity¿.It was reported that the hospital discards the explants and therefore cannot be returned for product analysis.

Event Description

It was reported that the vns patient went to the er on (b)(6) 2014 due to painful erratic stimulation.The er physician and neurologist stated that the patient¿s generator may be at end of service.The patient had not felt stimulation for the past eight months.Before going to the er, the patient was on a swing and was hanging by her left arm.The patient began experiencing painful stimulation at 45 second intervals.The patient was also experiencing tightening in her chest and reported that her magnet was not working.The patient had to press the magnet extremely hard against her generator to disable her device.Taping the magnet over the generator was ineffective in disabling the device.The patient was uncertain if her generator had migrated.The patient was seen by her neurologist on (b)(6) 2014.The neurologist decreased the patient¿s device settings during the office visit.The neurologist noted that the patient¿s voice alteration had significantly increased with stimulation.The patient felt that stimulation was traveling up her ear and around her temple.The physician stated that the generator pocket may have expanded and the generator may have migrated causing the magnet to activate magnet mode stimulation instead of disabling the device.The patient¿s device was tested during the office visit and diagnostic results showed lead impedance within normal limits.Further follow-up revealed that the patient underwent generator replacement surgery on (b)(6) 2014 but continued to have painful stimulation after surgery.The replacement device had been programmed on to the patient¿s previous device settings.A radiology report was received but did not observe any issues with the generator and lead.The patient was referred for lead replacement surgery.Lead replacement surgery has not occurred to date.Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012.A battery life calculation using the available programming history showed approximately 1.77 years until eri = yes.The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.

Manufacturer Narrative

Review of the available programming and diagnostic history.

Manufacturer Narrative

Describe event or problem; corrected data: inadvertently did not include that the lead replacement was due to a lead discontinuity on follow-up report #1.

• Brand Name: LEAD MODEL 302
• 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: 3840370
• MDR Text Key: 4581873
• Report Number: 1644487-2014-01382
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2011
• Device Model Number: 302-20
• Device Lot Number: 200799
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 07/15/2014
• Initial Date FDA Received: 05/30/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/09/2014; 07/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2008
• 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: 25 YR