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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 12/05/2014
Event Type  Injury  
Event Description

Additional information was received that the patient underwent generator replacement on (b)(6) 2015. The explanted generator is suspected to have been discarded by the explanting facility and will not be returned to the manufacturer; therefore, no product analysis can be performed.

 
Event Description

Additional information was received that the patient¿s explanted generator will be returned to the manufacturer but the explanted product has not been received to date.

 
Event Description

The explanted generator was received on 03/10/2015. In the pa lab, 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. The pulse generator diagnostics were as expected for the programmed parameters. There were no performance or any other type of adverse conditions found with the pulse generator.

 
Event Description

Clinic notes were received indicating that the vns patient was experiencing pain in the neck, throat, jugular, and chest during stimulation on-times. The patient described it as a choking feeling. It was also noted that the patient¿s apnea had worsened since vns. The physician did not decrease the patient's device settings due to potential effects of the decrease in therapy. The patient was referred for surgery but no known surgical interventions have occurred to date.

 
Manufacturer Narrative

 
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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 Key4377482
Report Number1644487-2015-03496
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 12/05/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/02/2015
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 Number2612
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/10/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/10/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/22/2010
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: 01/02/2015 Patient Sequence Number: 1
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