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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 01/01/2008
Event Type  Malfunction  
Event Description

Reporter indicated that pt received high lead impedance on system diagnostics. Chest and neck x-rays were reviewed by physician. No obvious lead breaks were found. Pt will have revision surgery.

 
Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
Event Description

It was reported that the patient experienced an increase in seizures in (b)(6) 2008. It was reported that the patient underwent surgery where a new vns system was placed on the right side. The revision surgery was previously reported in mfr. Report # 1644487-2009-00566. It was reported that the right sided vns was not as effective as the left system previous had been so the physician has agreed to explant the left vns system and implant a new system on the left side. Surgery is likely, but has not occurred to date.

 
Manufacturer Narrative

Corrected data: the lead and generator were explanted and the generator was returned to manufacturer for analysis. This information was inadvertently left off of supplemental mfr. Report #1. Corrected data: this information was inadvertently left off of supplemental mfr. Report #1.

 
Event Description

Further follow-up revealed that the underwent generator and lead replacement on (b)(6) 2013. It was reported that only the lead implanted on the right vagus nerve remains implanted and that the left vagus nerve system was replaced. Only the generator from the left system was returned for analysis on 09/25/2013. Analysis of the generator was completed on 10/15/2013. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant. A reset of the pulse disable bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Other than the noted condition, there were no performance or any other type of adverse conditions found with the pulse generator.

 
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Brand NameLEAD MODEL 302
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058 770
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 Key1062981
Report Number1644487-2008-01410
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/20/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/18/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2008
Device MODEL Number302-20
Device LOT Number1265
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received10/15/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2005
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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