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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 04/28/2010
Event Type  Malfunction  
Event Description

Our country manager for (b)(6) reported that there was a patient with high lead impedance on their system diagnostic testing. Over the last month it was reported that the patient experienced an increase in seizures at their pre vns baseline rate, new seizure type and tonic seizures with falls to the ground. Additionally it was reported that the patient had a violent fall in (b)(6) with trauma on the face. The patient had falls prior to vns implantation with their seizures and now, they have returned. The patient's seizures are being attributed to their high lead impedance/lead break. The patient's mother cannot remember tonic seizures with so violent falls before implantation. Reported it seems that these may be a new type of seizures. X-rays were reviewed at manufacturer and showed a gross lead discontinuity in the anchor tether area of the lead that is in the neck area. Lead replacement is scheduled for (b)(6) 2010. Good faith attempts will be made for the explanted product to be returned for product analysis.

 
Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device. Results: x-rays reviewed by manufacturer, gross lead discontinuity noted. Conclusions: device failure occurred, but did not cause or contribute to a death.

 
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Brand NameLEAD MODEL 302
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1724222
Report Number1644487-2010-01352
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/05/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/04/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2010
Device MODEL Number302-20
Device LOT Number200462
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/05/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2007
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: 06/04/2010 Patient Sequence Number: 1
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