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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 10/29/2012
Event Type  Malfunction  
Event Description

Clinic notes dated (b)(6) 2012 were received on (b)(4) 2012. The notes indicated that the patient was initially adamant that he has had not seizures or seizure-like activity and would know if he had. The patient's mother believed that he was having seizures (blacking out) but the patient was unaware. The patient eventually accepted the fact that he was having seizures. Programming history was provided. On (b)(6) 2012, diagnostic results indicated high impedance. A blc performed on (b)(4) 2012 indicated 2. 80 years remaining. Review of programming history showed that the patient's device was disabled between (b)(6) 2008 and (b)(6) 2009 for an unknown reason. Surgery is likely but has not taken place. Attempts for additional information have been unsuccessful.

 
Manufacturer Narrative

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

 
Event Description

An implant card was received on (b)(6) 2012 indicating that the patient underwent lead and generator revision on (b)(6) 2012. Attempts for additional information and product return have been unsuccessful. The new generator was programmed on after implant.

 
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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 Key2848905
Report Number1644487-2012-03123
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/01/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/28/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2006
Device MODEL Number302-20
Device LOT Number011314
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/31/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/04/2004
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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