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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 304

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CYBERONICS INC LEAD MODEL 304 Back to Search Results
Model Number 304-20
Event Date 01/10/2013
Event Type  Injury  
Event Description

It was initially reported that the patient went back into surgery following implant. The surgeon believed that he placed the electrode on the nerve upside down and took the patient back in to surgery to correct the placement. Diagnostics were within normal limits at implant surgery and were within normal limits following the electrode placement correction. There were no adverse events, the surgeon simply recalled that he placed them upside down and schedule the patient for surgery to correct them. There were no x-rays taken to confirm the event prior to the surgery.

 
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Brand NameLEAD MODEL 304
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 Key2942632
Report Number1644487-2013-00288
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 01/11/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/04/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2016
Device MODEL Number304-20
Device LOT Number3389
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/14/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/26/2012
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: 02/04/2013 Patient Sequence Number: 1
Treatment
NAQ
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