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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 03/06/2012
Event Type  Malfunction  
Event Description

Additional information was received as clinic notes including the most recent note dated (b)(6) 2012, that indicated that the patient has not had any seizures. The note on this date also details the high impedance being found and the patient indicating that she does not feel the device working likely as a result of the high impedance. A note dated (b)(6) 2012, indicates the physician checked the device on (b)(6) 2012 and it was noted that it "seems to be working well. " the vns was later checked and adjusted on (b)(6) 2012, however, no diagnostics or observations on the device performance were noted. The notes indicate the patient had an mri of her shoulder on (b)(6) 2012, which manufacturer labeling does not recommend.

 
Event Description

Additional information was received as an implant card indicating the lead and generator had been replaced. The explanted products will not be returned per hospital policy. Follow-up with the site found that it is believed that the previous system was explanted and the patient only has one vns system in place contrary to the previous indication by the site.

 
Event Description

It was reported that the patient's vns was now indicating high impedance on system and normal mode diagnostic tests. Source code from the generator from the last available date to the manufacturer on (b)(6) 2011, shows normal device function. Attempts for additional information have been unsuccessful to date. No adverse events have been reported. Surgery to replace the patient's lead and generator is likely.

 
Manufacturer Narrative

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

 
Event Description

Additional information was received as an implant card indicating that surgery to replace the patient's vns generator occurred on (b)(6) 2012. The lead was not replaced at that time. Additional information was later received indicating that the surgeon plans to implant a second lead on the right side instead of replacing the previous lead. The previous lead implanted on the left side likely has a fracture since the high impedance did not resolve following generator replacement. The generator implanted for the replacement on (b)(6) 2012 will be placed on the new lead. Surgery for lead revision and generator repositioning is likely.

 
Manufacturer Narrative

Initial report inadvertently did not indicate 30-day.

 
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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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2518527
Report Number1644487-2012-00913
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
Report Date 03/06/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/05/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2011
Device MODEL Number302-20
Device LOT Number2205
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/11/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/08/2008
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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