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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Device Problem Detachment Of Device Component
Event Date 10/23/2017
Event Type  Malfunction  
Event Description

It was reported that during a repositioning surgery, the septum plug came out of the generator and was unable to be secured in its original place. A new generator was placed instead. The explanted device has not been received by the manufacturer to-date.

 
Event Description

The explanted device was received by the manufacturer. Analysis is underway, but has not been completed to-date.

 
Event Description

Analysis was completed for the returned generator. The device output signal was monitored for more than 24 hours, while the pulse 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. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery measured 2. 966 volts and was not in a depleted condition. The downloaded data revealed that 2. 772% of the battery had been consumed. The reported detachment of the septum plug was observed as the septum was not returned for evaluation. The header septum cavity meets specification. Therefore, a root cause for the condition could not be determined. There were no performance or any other type of adverse conditions found with the pulse generator.

 
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Brand NamePULSE GEN MODEL 106
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
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 Key7042821
Report Number1644487-2017-04811
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 01/12/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/17/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/15/2019
Device MODEL Number106
Device LOT Number204081
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/11/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/09/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/11/2017
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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