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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 104 GENERATOR

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CYBERONICS INC PULSE GEN MODEL 104 GENERATOR Back to Search Results
Model Number 104
Event Date 06/23/2014
Event Type  Malfunction  
Event Description

On (b)(6) 2014, it was reported that this vns patient was referred for generator revision for an unknown reason. On (b)(6) 2014, a tc present at the patient¿s appointment preformed diagnostics: diagnostics were within normal limits. The generator was reported to be being replaced due to generator nearing end of service. The patient underwent generator revision on (b)(6) 2015. The generator was returned and underwent product analysis. Analysis was approved on (b)(6) 2015 and identified that the generator had reached a near end of service state sooner than expected based on a battery life calculation and an analysis of the generator¿s charge consumption counter. A review of the generator¿s device history record revealed that it was likely left programmed on to a high output state as a result of an incomplete final electrical test (fet) at the time of manufacture. The generator likely stayed in this high output state for months before being subjected to fet again, effectively programming the generator off. During the time in between fet tests, the generator is believed to have used a significant amount of battery capacity, resulting in the discrepancy identified in product analysis. There were no additional performance or any other type of adverse conditions found with the pulse generator. Review of the dhr shows that the device did pass all functional specifications prior to distribution. Review of in-house programming history shows that the ifi-indicator was first seen on (b)(6) 2014.

 
Manufacturer Narrative

Programming history and device history records were reviewed. No device failure occurred; however, the device did reach an end of life condition earlier than expected due to the generator remained programmed to a high output state during manufacturing. The event did not cause or contribute to a death or serious injury.

 
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Brand NamePULSE GEN MODEL 104
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
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 Key4618213
Report Number1644487-2015-04023
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/19/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/19/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/10/2014
Device MODEL Number104
Device LOT Number3402
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/20/2015
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received02/19/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/13/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number001-C

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