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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 06/02/2014
Event Type  Injury  
Event Description

During review of the available programming and diagnostic history, it was observed that the vns patient¿s device was disabled on (b)(6) 2004. Follow-up revealed that the patient underwent surgery on (b)(6) 2004 to explant her generator due to neck pain and lack of efficacy. The relationship between the neck pain and vns is unknown. The patient¿s neck pain was not related to stimulation and continued despite generator explant. The patient¿s lack of efficacy was attributed to the time needed to ramp up the patient¿s device settings to therapeutic levels. No patient manipulation or trauma was reported that may have caused or contributed to the patient¿s neck pain. The explanted generator has not been returned to date.

 
Manufacturer Narrative

(b)(4).

 
Event Description

On august 21, 2014 product analysis was completed on an explanted generator. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the product analysis 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铠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. The generator performed according to functional specifications; there were no anomalies found with the pulse generator. Product analysis on the lead was completed on august 26, 2014. Scanning electron microscopy image of the connector pin surface with opaque appearance shows that pitting or electro-etching conditions have occurred on the pin. Since portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. No other anomalies were identified in the returned lead portion.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
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 Key3946880
Report Number1644487-2014-01833
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/25/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/21/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number302-20
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/21/2014
Was Device Evaluated By Manufacturer? Yes
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: 07/21/2014 Patient Sequence Number: 1
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