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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Device Problems Failure to Deliver Energy ; Unexpected Therapeutic Results
Event Date 01/20/2015
Event Type  Injury  
Event Description

Clinic notes were received on (b)(6) 2015 for referral for battery replacement due to less efficacy being received from the device. Notes dated (b)(6) 2015 state that the patient has had few seizures and seizures are infrequent. The patient does not recall any seizures in the prior months. Follow-up showed that the patient is having an increase in seizure activity which is why less efficacy is thought to be received. The physician is concerned because her seizures have now included cluster seizures which is a new seizure type for the patient. It was noted that the patient doesn¿t feel stimulation as much and seizures have been aborted with magnet activation. There have been no change in medications leading to the increase in seizure activity. The patient can't tolerate vns settings beyond 1. 75ma. The physician opted for prophylactic replacement and increased her oral medications until surgery. Surgery is likely but has not occurred to date.

 
Manufacturer Narrative

Review of the available programming and diagnostic history.

 
Event Description

The patient underwent replacement surgery on (b)(6) 2015 due to prophylactic neos=no. The explanted generator was received for analysis on 10/23/2015. Analysis is currently underway but has not been completed to date.

 
Event Description

Product analysis for the m102 generator was completed and approved on 11/17/2015. Based on the electrical test results, the device exhibited current consumption rates that are within specification, thereby demonstrating normal battery depletion to an eri condition. Therefore, the electrical performance of the generator, as measured in the product analysis lab, will be used to conclude that no anomalies exist and the eri condition is an expected event. The device output signal was monitored for more than 24-hrs, 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. In addition, a comprehensive automated electrical evaluation showed that the pulse generator module performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

 
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Brand NamePULSE GEN MODEL 102
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 Key4848231
Report Number1644487-2015-04910
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 05/27/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/16/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2008
Device MODEL Number102
Device LOT Number015030
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/23/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/17/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/08/2006
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: 06/16/2015 Patient Sequence Number: 1
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