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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
Event Date 09/12/2011
Event Type  Injury  
Event Description

On (b)(6) 2013, it was reported that this vns patient underwent full explant on (b)(6) 2013 due to pain the chest and arm although the device had not been disabled for some time. The lead and generator were returned on (b)(4) 2013 and are pending analysis.

 
Manufacturer Narrative

 
Event Description

Product analysis of the generator was performed. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. 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. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. A cut was identified in the positive coil. Although, not conclusive, it appears this observed condition is the result of the explant procedure. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Dried remnants of what appeared to be dried fluid was seen inside the inner tubing. There was no obvious point on entry other than the cut ends and the mentioned cuts. Other than the above mentioned observations typical wear, and explant related observations, no anomalies were identified in the returned lead portions.

 
Event Description

On (b)(6) 2013, it was reported by the patient that the pain she was experiencing was causing her depression to increase. She stated that she wanted the device explanted. Attempts were made for additional information on the pain; however, they were unsuccessful. No additional information has been provided. Surgery is likely, but has not occurred to date.

 
Manufacturer Narrative

 
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Brand NamePULSE GEN MODEL 102
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 Key3473303
Report Number1644487-2013-03507
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/17/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/15/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/26/2007
Device MODEL Number102
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/11/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/06/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/28/2005
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: 11/15/2013 Patient Sequence Number: 1
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