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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
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.

 
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Brand NameLEAD MODEL 304
Type of DeviceLEAD
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 Key3622212
Report Number1644487-2014-00381
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 10/31/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/11/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2017
Device MODEL Number304-20
Device LOT Number3713
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/06/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/26/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/11/2014 Patient Sequence Number: 1
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