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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 100

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CYBERONICS, INC. PULSE GEN MODEL 100 Back to Search Results
Model Number 100
Event Date 12/04/2001
Event Type  Injury  
Event Description

It was reported that a patient underwent generator revision surgery due to vibrating pain that occurred in the left axilla during stimulation on times. Once the patient's device was replaced, the pain appeared to resolve. Good faith attempts to obtain additional information from the patient's treating physician have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 100
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1504664
Report Number1644487-2009-02284
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/14/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/13/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2000
Device MODEL Number100
Device LOT Number20843C
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received09/14/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/1999
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: 10/13/2009 Patient Sequence Number: 1
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