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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103

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CYBERONICS, INC. PULSE GEN MODEL 103 Back to Search Results
Model Number 103
Event Date 03/01/2010
Event Type  Injury  
Event Description

It was reported that a patient wanted to have the device removed because it had migrated to one end and was protruding. The patient did not believe that it was effective in treating her depression. The patient's physician confirmed that the device did appear to be more visible in the patient's chest. There were no reports of trauma or manipulation of the device. The reason for the migration is unknown. The patient has been referred to a neurosurgeon. Good faith attempts to obtain additional information have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 103
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste. 600
houston , TX 77058
2812287200
MDR Report Key1671173
Report Number1644487-2010-01007
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 03/29/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/27/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2010
Device MODEL Number103
Device LOT Number200882
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/29/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2008
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: 04/27/2010 Patient Sequence Number: 1
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