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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102

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CYBERONICS, INC. PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 09/10/2003
Event Type  Injury  
Event Description

In review of patient's programming history, it was noted that a vns patient's device was disabled on (b)(6) 2003. Follow-up information was obtained from the patient's physician and it was revealed that the patient had been disabled due to an episode of loss of consciousness with magnet use. However, the patient's stimulation was re-enabled on (b)(6) 2008, and there had been no recurrence of the episodes. The generator was later replaced prophylactically for an unrelated reason and was returned to the manufacturer for analysis. The device performed according to functional specifications, and there was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. Good faith attempts to gain more information have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
suite 600
houston , TX 77058
2812287200
MDR Report Key2032419
Report Number1644487-2011-00633
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/23/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/25/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number102
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer12/09/2010
Is The Reporter A Health Professional? Yes
Date Manufacturer Received02/23/2011
Was Device Evaluated By Manufacturer? Yes
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: 03/25/2011 Patient Sequence Number: 1
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