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

Model Number 302-20

Device Problem Moisture or Humidity Problem (2986)

Patient Problem Seizures (2063)

Event Date 03/30/2016

Event Type  malfunction  

Event Description

It was reported that vns patient has severe hoarseness.The system diagnostics seem ok.The x-rays seem normal.They also did an evoked potential recording and it seems that the generator creates an irregular stimulation pattern; no indication of a defective lead is present.Through a decrease of the output current from 2.25 ma to 1 ma the patient has an increase of seizures that was linked to loss of therapy as per the doctor.The physician has decided to replace the generator with an aspire sr and planned the surgery.The customer requested a reimbursement if the product analysis confirmed a faulty generator.The review of the generator's manufacturing records confirmed all tests passed for the device prior to distribution.The review of the received x-rays indicated that the lead pin is fully inserted into the generator block, no anomalies were observed on the assessed x-ray images (no neck x-ray was provided).The received programming history was reviewed from 07/01/2015 to 03/29/2016.Parameters data also indicated that the stimulation ok.The review of the available programming history did not reveal any anomalies.Magnet activations were reviewed from 11/01/2015 until 03/29/2016, it was observed that the patient used the magnet about 3 times a day.Follow up indicated that the patient underwent a surgery; the neurosurgeon found some moisture in the lead and decided not to replace the generator without replacing the lead or generator.As no lead was available as backup, the surgery was postponed.The generator was dislocated and re-fixated accordingly.It was also reported that an evoked potentials monitoring was performed after the surgery and this showed an abnormal result.The surgeon is planning to replace the generator and lead in the next time, no date is known at this time.

Event Description

Additional information was received from physician that replacement surgery is planned for (b)(6) 2016.

Event Description

Follow up indicated that the lead replacement surgery was performed on (b)(6) 2016.The system diagnostic test was ok and the patient health state is fine.

• 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: 5769215
• MDR Text Key: 49539503
• Report Number: 1644487-2016-01496
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2016

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: 07/31/2013
• Device Model Number: 302-20
• Device Lot Number: 2423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/08/2016
• Initial Date FDA Received: 07/05/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/04/2016; 09/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2009
• 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: 38 YR