MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

Model Number 304-20

Device Problem High impedance (1291)

Patient Problems Headache (1880); Pain (1994); Neck Pain (2433); No Code Available (3191)

Event Date 01/05/2014

Event Type  malfunction  

Event Description

It was reported that the patient's vns device had high lead impedance.Follow up with the physician found that the high lead impedance was observed on (b)(6) 2014.The vns device was programmed off to 0ma following the observation of the high lead impedance.The patient stated that she came into contact with a large magnet over christmas ((b)(6) 2013) and felt strange afterward.The physician will not provide any additional information.Ap and lateral chest and neck x-rays dated (b)(6) 2014 were received and reviewed by the manufacturer.The generator appears normally placed in the left chest.It cannot be assessed if the lead pin is fully inserted as the lead pin is not visible past the connector block.Feed thru wires appear intact.Lead wires appear intact at the connector pins.The lead coils behind the generator before routing upward to the left neck.The portion of lead behind the generator cannot be assessed.The electrodes appear aligned.A strain relief bend is present and appears to be per labeling.No strain relief loop is present.Two tie-downs are visible; however, the tie-downs are not placed per labeling as the first tie-down is not positioned laterally to the anchor tether.There do not appear to be any gross fractures, discontinuities, or sharp angles in the lead.There are several slivers in the neck area near the electrode; however, these appear to be behind the lead body and not interacting with the lead.No other information has been provided.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records confirmed the device met all final testing specifications prior to distribution.Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative

(b)(6).

Event Description

The patient reported via facebook comment in 2017 that the vns caused voice alteration and at a higher dose, she felt discomfort in her left neck, left lower tooth and left side of forehead for which her neurologist adjusted dose and time interval in response.She indicated that depending on the slant of her head, she felt that the vns was more intense.In addition, the patient reported brain freezes when she had to take her medications with cold water.She believed it was possible that the vns was going off at that time and causing it.The patient reported during follow-up with company representatives that her vns wasn't changed after high impedance a couple of months after having a cough.She said that she ended up getting pneumonia.The treating neurologist's nurse indicated that while the patient's pneumonia and the high impedance was noted in the patient's clinic notes, she didn't see anything connecting the pneumonia to the high impedance.The programming database and internal data of the patient's generator was reviewed.Per the data, it was found that the patient's generator was re-enabled.Also, it was found that the patient's impedance appeared to be fluctuating from high to normal until (b)(6) 2014, after which there was no further incidents of high impedance.No known relevant surgical intervention has occurred to date.No further relevant information has been received to date.

• Brand Name: LEAD MODEL 304
• 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: 3622212
• MDR Text Key: 4158265
• Report Number: 1644487-2014-00381
• 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,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2017
• Device Model Number: 304-20
• Device Lot Number: 3713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2013
• 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): Other
• Patient Age: 50 YR