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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 03/01/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that the patient is reporting increased seizures, nausea, vomiting with magnet use, increased irritability, extreme voice hoarseness, left throat pain, and incisional pain over the generator. The patient was recently implanted on (b)(6) 2016. The device was turned on to 0. 25ma last week. She returned on (b)(6) 2016 with the above complaints and when system diagnostics was performed it resulted in high impedance over 10,000 ohms. X-rays also show that the generator lead coiled and disconnected from radiopaque structure in left supraclavicular area indicating disrupted vns. It was instructed to turn the device to 0. 0 ma and refer the patient to surgery for replacement. Clinic notes received on (b)(6) 2016 and dated (b)(6) 2016 state that patient believes seizures are worse since the operation. It was mentioned that the patient had a convulsion on (b)(6) and fell, hitting her nose and may have caused trauma to the device as she did mention she could feel it moving in her chest. Post-op symptoms (with device off) included weight loss, nausea, vomiting, increased headaches, and notable negative change in mood. The week prior she was initially activated at the output current of 0. 25 ma with minimal side effects. Over the past week, she has had significant reaction to the device with increasing hoarseness, left throat pain, incisional pain, worsened mood and nausea and vomiting with magnet use. Notes state that from her post-op convulsion, it is suspected that the disconnection of the lead and generator seen on x-rays is likely from her fall and will require surgery to correct the connections. Notes from initial implantation on (b)(6) 2016 also confirm that a non-absorbable suture was used to secure the generator to the pocket. Follow-up showed that the patient is referred for surgery on (b)(6) 2016. The voice hoarseness was stated to sometimes occur with stimulation on times. The left throat pain was occurring both with stimulation and without. It was stated that it is unknown if the increase in seizures is attributed to the high impedance but the level is approximately the same as baseline. It is unknown if the tinnitus, worsened mood, increased headaches, weight loss are attributed to vns therapy or high impedance. X-rays are not available for review.

 
Event Description

Patient had surgery on (b)(6) 2016. The lead had a complete break with multiple knots, indicative that the patient twisted the device. The patient also must have twisted the generator as it was no longer anchored to the fascia. It is believed that the patient's fall as well as manipulation contributed to the break. The lead was received for analysis on 04/21/2016. Product analysis is underway but has not been completed to date.

 
Event Description

Product analysis for the lead was completed and approved on 05/18/2016. A break was identified in both positive and negative lead coils. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the coil end. Scanning electron microscopy images of both positive and the negative coils suggest a stress¿induced fractured (due to rotational forces) occurred. Scanning electron microscopy images of the negative coil at the break located past the anchor tether show that a stress-induced fracture (due to rotational forces) occurred on the coil. The overall appearance of the lead coils past the electrode bifurcation is consistent with patient manipulation of the implanted device, a ¿twiddler. ¿ the inner silicone tubing of the negative coil has dried remnants of what appear to have once been body fluids inside the inner silicone tubing at the break location.

 
Event Description

Clinic notes received stated that the patient had complications of left vocal cord paresis and disconnection of leads from generator and had a new lead implanted. It appears that the vocal cord paresis that the patient had was likely related to the device failure. No additional or 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 Key5551724
Report Number1644487-2016-00725
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Followup,Followup
Report Date 11/20/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/06/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number304-20
Device LOT Number203631
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/21/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/31/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/30/2015
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: 04/06/2016 Patient Sequence Number: 1
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