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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 07/04/2005
Event Type  Malfunction  
Event Description

During review of the programming history it was noted that he patient had high impedance. The patient had previously reported a lack of efficacy and painful stimulation in her chest as well as reporting that she did not feel magnet and normal stimulation. The patient had the generator and lead explanted due to the lack of efficacy. Product return attempts are in process. Follow-up with the treating neurologist at that time indicated that they had not seen the patient in a number of years and they no longer have any records for the patient. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator and lead prior to distribution.

 
Event Description

Additional information indicated that the generator and lead were likely discarded. The hospital does not return explanted product due to the time and cost factor.

 
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.

 
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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 Key3167486
Report Number1644487-2013-01771
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/16/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/13/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2007
Device MODEL Number302-20
Device LOT Number11767
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/14/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/19/2005
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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