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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 09/08/2010
Event Type  Malfunction  
Event Description

The explanted lead and generator were returned and underwent analysis. An implant card and returned product form were received indicating the reason for replacement was lead discontinuity. The entire lead was not returned. No anomalies were observed in the returned lead portions except two abraded openings in the outer tubing. Analysis of the generator found it performed to functional specifications.

 
Event Description

Attempts for additional information have been unsuccessful to date.

 
Manufacturer Narrative

Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury. Type of report, corrected data: initial report inadvertently did not indicate "30-day. ".

 
Event Description

It was reported that the patient's vns was now indicating high impedance. The patient's mother indicated that the patient's generator is implanted underneath his armpit due to his young age. The mother indicated that the patient roughhoused on occasion and they also frequently picked the patient up from under his armpits. Per the mother, the patient had been experiencing an increase in seizures below the pre-vns baseline seizure frequency since (b)(6) 2011. The magnet no longer was aborting seizures and the patient's voice no longer changed with stimulation around this time as well. No x-rays have been taken to evaluate for a lead fracture. The device has reportedly not been disabled as recommended in manufacturer labeling. Review of the programming history available to the manufacturer found that the lead impedance was normal on (b)(6) 2010 at 2900 ohms however, a significant change in impedance occurred on (b)(6) 2010 when the impedance changed from 5386 ohms to 2700ohms. This could be indicative of an intermittent lead issue beginning at that time eventually developing into the current issue. Surgery to replace the patient's lead and generator has occurred. Attempts for the return of the explanted products and for additional information are in progress.

 
Manufacturer Narrative

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

 
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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 Key2596398
Report Number1644487-2012-01400
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/02/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/01/2012
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? Device Returned To Manufacturer
Date Returned to Manufacturer06/04/2012
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/24/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/07/2008
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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