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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 03/18/2008
Event Type  Malfunction  
Event Description

Analysis of a generator that was returned was completed on (b)(4) 2014. The battery showed a non-ifi condition. A review of the internal memory locations within the generator suggests the existence of an error in calculating the device's total consumed energy. This error results in an incorrect device longevity estimate. This event was previously investigated and this generator was found on the list of devices for this error. In addition, a review of the vns programming history database printout (shows ifi) and the internal memory locations within the generator verified the existence of an error in calculating the device's battery voltage. Additional monitoring of the device was requested. The pulse generator was programmed to the last known parameters from the vns programming history database (no as received parameters) and to the as received percent of battery capacity to monitor diagvbat for a period of time. The pulse generator showed no anomalies during the period that diagvbat was monitored. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specification. Other than the noted errors, there were no performance or any other type of adverse conditions found with the pulse generator.

 
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Brand NamePULSE GEN MODEL
Type of Device103
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 Key3675337
Report Number1644487-2014-00672
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/11/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/12/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2010
Device MODEL Number103
Device LOT Number2020
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/14/2013
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received02/11/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/18/2008
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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