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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 01/01/2012
Event Type  Injury  
Event Description

It was initially reported on (b)(6) 2012, that a vns patient wanted to have her device removed because the battery was dead and when she works out, it causes some pain in her arm. The patient later stated that the vns device never really helped much and was also causing numbness and pain in her arm. Good faith attempts to obtain additional information were unsuccessful. During a review of the patient's programming data available in the in-house programming database, it was noted that the device was programmed off on (b)(6) 2010, however this was the last date of data so it is unknown if the device was programmed back on at a later date or if has remained off. The generator was explanted and not replaced on (b)(6) 2012. The generator will not be returned to the manufacturer for analysis.

 
Event Description

Additional information was received on (b)(6) 2012 when it was reported that the explanted generator was available for return. The explanted generator was returned to the manufacturer on (b)(4) 2012 and product analysis is underway.

 
Event Description

Additional information was received on (b)(6) 2012, when analysis of the explanted generator was completed. During the analysis, it was observed that the septum was not cored thus eliminating the possibility of a potential unintended electrical current path through body fluids. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

 
Manufacturer Narrative

Analysis of programming history performed.

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
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 grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2535518
Report Number1644487-2012-00975
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/21/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/13/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/07/2008
Device MODEL Number102
Device LOT Number015852
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/01/2012
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/04/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/09/2006
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: 04/13/2012 Patient Sequence Number: 1
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