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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 05/01/2012
Event Type  Malfunction  
Event Description

It was reported that the patient's vns was now indicating high lead impedance. Follow-up with the site found the high impedance is believed to be related to the electrode no longer being on the nerve based on ct scans taken in may of 2012. No trauma or manipulation is believed to have caused or contributed to the high lead impedance. The patient was noted as having an "exponential" decrease in seizures with vns however they suspected an issue when the seizures began to return. The increased seizures are back at the pre-vns baseline. The patient was noted as now "playing" with the lead in his neck which is in a ball that can be felt by the patient. The magnet has been used to temporarily disable the patient's vns however the site has not had a chance to turn off the patient's vns. The patient was noted as experiencing voice alteration following vns implant which went away but has now returned with the high impedance. Last known diagnostics were not available upon request. Surgery to replace the lead and generator is likely.

 
Event Description

Additional information was received that the patient had a generator and lead replacement. Only the generator was returned to the manufacturer for evaluation. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator and lead prior to distribution.

 
Event Description

Review of decoder data shows that the device impedance went from 4137 ohms to 3039 ohms on (b)(6) 2011. The as-received decoder does not indicate that high impedance was ever seen. Of note, the generator was returned programmed to 1 hz. It is unknown when this was programmed.

 
Manufacturer Narrative

Device failure is suspected.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator and lead prior to distribution. Describe event or problem: corrected data: follow-up report #1 inadvertently did not include the information that the lead and generator were replaced and that the generator was returned to the manufacturer for evaluation. If explanted, give date (mo/day/yr): corrected data: follow-up report #1 inadvertently did not include the explant date of the lead.

 
Event Description

Additional information was received that product analysis was completed on the generator. Results of diagnostic testing indicated the device was operating properly. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator.

 
Event Description

On (b)(6) 2013 the physician¿s nurse stated that per the operative note from surgery, the old generator was removed from the pocket, and a replacement device was connected to a lead and the lead was found to be functioning normally. The battery was put back into the pocket and tested again with normal impedance and proper lead function found. She said that it does not appear from the notes that any other actions were taken except replacing the generator which reportedly resolved the high impedance. However, per the implant card, the patient's lead was indeed replaced. They have not heard from the patient since the surgery so assume everything is okay. It was not dictated in the notes if the electrode was off of the nerve. No additional information or clarification could be provided.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
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 Key2825195
Report Number1644487-2012-02931
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/09/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/08/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2014
Device MODEL Number302-20
Device LOT Number2567
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/23/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/12/2010
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: 11/08/2012 Patient Sequence Number: 1
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