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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. BIPOLAR LEAD MODEL 300

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CYBERONICS, INC. BIPOLAR LEAD MODEL 300 Back to Search Results
Model Number 300-30
Event Date 11/01/2009
Event Type  Injury  
Event Description

It was initially reported by the nurse that the pt is complaining about pain in his neck and collar bone area during stimulation. Diagnostics was done on the pt and it showed everything working within normal limits (ok, ok 1, no). The treating physician reduced the output current from 2 ma to 1 ma and signal off time from 5 min off to 1. 8 min off. X-rays were taken and there was no lead fracture or acute angles found. No anomaly was noticed on the x-rays as stated by the nurse. Additional info received revealed that the pt had a full revision surgery due to neck pain. Implant card stated dcdc code of 0 on normal and system mode diagnostics. It is unk if the dcdc 0 was on the new device or the old one. Good faith attempts to obtain additional info have been unsuccessful. Device has not been returned for analysis as yet but they are on their way.

 
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Brand NameBIPOLAR LEAD MODEL 300
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste. 600
houston , TX 77058
2812287200
MDR Report Key1618579
Report Number1644487-2010-00477
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/28/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/26/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2004
Device MODEL Number300-30
Device LOT Number30673
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/28/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2002
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: 02/26/2010 Patient Sequence Number: 1
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