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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 11/03/2014
Event Type  Malfunction  
Event Description

On 11/07/2014, it was reported that this vns patient underwent generator revision on (b)(6) 2014 due to end of service. The generator was returned on (b)(4) 2014 and underwent product analysis. On (b)(6) 2015, this generator was identified as having been affected by a manufacturing error that led to the generator remaining programmed on to a high output state for several months. During the time that the device remained programmed on, the generator is believed to have used a significant amount of battery capacity. The calculated projected life accounting for the time that the device remained on did not meet the design requirements for battery longevity. As a result of this, the generator reached an ifi status indicator earlier than expected. Product analysis was approved on (b)(6) 2015. In the pa lab, the pulse generator diagnostics were as expected for the programmed parameters, and a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The device was found to be an ifi-yes battery status. Product analysis confirmed that the generator reached a ifi-yes state sooner than expected based on a battery life calculation and an analysis of the generator¿s charge consumption counter. Other than this noted condition, there were no additional performance or any other type of adverse conditions found with the pulse generator.

 
Manufacturer Narrative

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 103
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 Key4618238
Report Number1644487-2015-04166
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 Date02/28/2014
Device MODEL Number103
Device LOT Number202198
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/11/2014
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received02/19/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/07/2012
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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