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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 07/28/2014
Event Type  Injury  
Event Description

Clinic notes were received indicating that the vns patient had been experiencing an increase in seizures for the past three weeks prior to his office visit on (b)(6) 2014. The patient also began having several generalized tonic-clonic seizures which have not been observed while the patient has had vns. Following vns, the patient has had three primary seizure types: (1) tonic movements of the arms with head deviation to the left, (2) chewing automatisms with head bobbing of the head and neck, and (3) facial grimacing. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2011. The patient was referred for surgery but no known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

Analysis was completed on the explanted generator. There were no performance or any other type of adverse conditions found with the pulse generator. The device output signal was monitored for more than 24-hours, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.

 
Event Description

An implant card was received and reported that the reason for generator replacement was battery depletion.

 
Manufacturer Narrative

Review of the available programming and diagnostic history.

 
Event Description

The patient had generator replacement on (b)(6) 2015. The generator was received by the manufacturer for analysis. However, analysis has not been completed to date.

 
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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 Key4184637
Report Number1644487-2014-02752
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 09/24/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/20/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2011
Device MODEL Number103
Device LOT Number2624
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/08/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/09/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/31/2010
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: 10/20/2014 Patient Sequence Number: 1
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