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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 04/22/2014
Event Type  Injury  
Event Description

It was reported that the patient underwent generator replacement due to battery depletion. The explanted generator was received for analysis. Analysis is underway, but has not been completed to date.

 
Event Description

Clinic notes dated (b)(6) 2013 and (b)(6) 2014 were received indicating that the vns patient was experiencing seizures daily. Notes dated (b)(6) 2014 indicate that the patient was having breakthrough seizures. The neurologist stated that the patient¿s device may not be working. The patient¿s device settings and medication were increased. The patient¿s device was at an ifi condition. The patient was referred for surgery but no known surgical interventions have occurred to date. Using the generator battery longevity table at the patient¿s last known programmed settings on (b)(6) 2014, the approximate battery life from beginning of life (bol) to end of service is 2 years.

 
Event Description

Analysis of the explanted generator was completed. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The reported ifi=yes battery status was duplicated. There are no performance or any other type of adverse conditions that would have effect on battery longevity found with the pulse generator.

 
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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 Key3827970
Report Number1644487-2014-01311
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/23/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/22/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2015
Device MODEL Number103
Device LOT Number202466
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/19/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/21/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/01/2013
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: 05/22/2014 Patient Sequence Number: 1
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