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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 03/26/2014
Event Type  Malfunction  
Event Description

It was reported that the vns patient underwent generator replacement surgery on (b)(6) 2014 due to battery depletion. The patient¿s generator could not be interrogated during the procedure prior to replacement. The programming system is not expected to have caused or contributed to the event as it has successfully interrogated with other generators following the replacement surgery. A battery life calculation using the available programming history and prediction tables showed approximately 4. 8 years from beginning of life to end of service. The explanted generator has been returned to the manufacturer where analysis is currently underway.

 
Event Description

Analysis of the generator was completed on 10/28/2014. The pulse generator was placed at a distance of one-inch (spacer block) from the programming wand and interrogated at multiple orientations adjacent to the programming wand. The pulse generator interrogated at all orientations. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery shows an ifi condition. There were no performance or any other type of adverse conditions found with the pulse generator.

 
Manufacturer Narrative

Review of the available programming and diagnostic history.

 
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Brand NamePULSE GEN MODEL 103
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3761647
Report Number1644487-2014-01065
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/26/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/21/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2011
Device MODEL Number103
Device LOT Number2550
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/07/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/28/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/27/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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