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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
Device Problems Fracture; High impedance
Event Date 05/13/2017
Event Type  Malfunction  
Event Description

It was reported on (b)(6) 2017 that the patient had high impedance. Her device was disabled. Clinic notes reported that the patient felt that the magnet wasn't working as the magnet swipes didn't make her cough like typically had before. No known surgical intervention has occurred to date. No further relevant information has been received to date.

 
Event Description

The patient underwent full revision surgery due to the high impedance. During explant of the lead, the surgeon noted that the patient's lead was not attached to the vagus nerve. All parts of the lead were anterior to the carotid artery. The surgeon said that the electrodes were around 0. 5 inches away from the vagus nerve. The suspect device has not been received to date. No further relevant information has been received to date.

 
Event Description

The patient's lead and generator were received into product analysis. Pa was completed on the returned lead. The lead was returned in 3 portions without tie-downs. Set screw marks were observed on the lead pin, indicating that at one point in time, there was a good electromechanical connection between the lead and generator. The condition of the returned lead portions was consistent with those that typically exist following an explant procedure. No obvious anomalies were noted. Continuity checks of the returned lead portions were performed during the visual analysis, and no discontinuities were identified. Product analysis was completed on the returned generator. The generator was monitored in a simulated body-temperature environment for over 24 hours. The generator provided the expected output current for the entirety of the monitoring period. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrated that accurate resistance measurements were obtained in all instances. The generator performed according to functional specifications with no anomalies found. The surgeon and the treating physician indicated that they didn't know what caused the patient's electrode to migrate off the nerve. The treating physician did not know of any trauma to the neck site. No further relevant information has been received to date.

 
Manufacturer Narrative

Supplemental mdr 1-- describe event or problem, corrected data:supplemental mdr 1 inadvertently reported that the suspect product hadn't been received instead of "the suspect lead and the generator were received and pending completion of product analysis. " supplemental mdr 1-- device available for evaluation?, corrected data: supplemental mdr 1 inadvertently reported that the patient's product had not been received. However, prior to submission the mdr the product was received on 08/31/2017. Supplemental mdr 2-- date received by manufacturer (mo/day/yr), corrected data: supplemental mdr 2 inadvertently reported 08/31/2017 as the aware date instead of 09/13/2017.

 
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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 Key6694894
Report Number1644487-2017-04111
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 09/26/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/07/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2016
Device MODEL Number304-20
Device LOT Number3316
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/31/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/26/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/24/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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