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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 01/23/2015
Event Type  Malfunction  
Event Description

It was reported that during generator replacement surgery device diagnostics with the new generator and existing lead were within normal limits both inside and outside of the generator pocket and once the incision was closed device diagnostics showed ifi - yes. It was reported that electrocautery was not brought back into the field during incision closure; however, it was on the table near the patient which may have discharged during incision closure. A new generator was then implanted. A device programming decoder showed that the battery voltage changed from 3. 354v to 2. 022v between 9:04:31 and 10:00:41 on (b)(6) 2015. The generator was received for analysis. Analysis is underway, but has not been completed to date.

 
Event Description

Analysis of the returned generator was completed. An end-of-service warning message was verified and found to be associated with the output being disabled by the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device implant or explant. A reset of the pulsedisable bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. The battery of the returned generator was measured as 3. 095 volts showing an ifi=no condition. The downloaded data revealed that 1. 629% of the battery had been consumed. Other than the observed pulse disablement and burn marks, there were no performance or any other type of adverse conditions found with the pulse generator.

 
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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 Key4532316
Report Number1644487-2015-03923
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/23/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/20/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2016
Device MODEL Number103
Device LOT Number203031
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/27/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/23/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/16/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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