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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 09/01/2014
Event Type  Injury  
Event Description

It was reported that the patient was having painful stimulation in his throat that he believed to be due to the generator reaching end of service. The patient stated that something similar occurred when his last generator reached end of service. The patient also reported that the generator was going off more often. The physician confirmed that the generator was not at end of service but the patient was insistent to have it replaced. Surgery is likely but has not occurred to date.

 
Event Description

On (b)(6) 2014 it was reported that the patient underwent prophylactic generator replacement on (b)(6) 2014. The explanted generator was returned for product analysis on (b)(6) 2014. Product analysis is still underway and has not yet been completed.

 
Event Description

On (b)(6) 2014, product analysis was completed on the 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¿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. The generator performed according to functional specifications, there were no anomalies 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 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 Key4209245
Report Number1644487-2014-02863
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/30/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/29/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2011
Device MODEL Number102
Device LOT Number2344
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/24/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/11/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/04/2009
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: 10/29/2014 Patient Sequence Number: 1
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