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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 06/18/2014
Event Type  Malfunction  
Event Description

It was reported that while attempting interrogation on a vns patient's generator the handheld showed a "check sum" error and showed the generator at 50% battery life. It was reported that the patient's generator had been recently implanted. Another handheld was utilized and the interrogation was successful and no longer showed 50% battery life. A new programming tablet was requested and the handheld was returned for analysis. Analysis is underway, but has not been completed to date.

 
Event Description

The programming history decoder identified that the interrogation performed on (b)(6) 2014 identified no problems with the device. The lead impedance was within normal limits (2465 ohms). No anomalies were identified.

 
Manufacturer Narrative

Corrected data: initial and follow-up mfr. Report inadvertently reported on the incorrect suspect device.

 
Event Description

Analysis of the handheld was completed on (b)(6) 2014. No anomalies associated with the handheld performance were noted during testing using the ac adapter or the main battery with a full charge. The handheld performed according to functional specifications. Analysis of the flashcard was completed on (b)(6) 2014. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications. Programming history from the handheld showed that device interrogation on 06/18/2014 showed the battery status as ok.

 
Manufacturer Narrative

New information corrects the date of event. This was inadvertently left off of follow-up mfr. Report #01.

 
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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 Key3938452
Report Number1644487-2014-01800
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 06/19/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/16/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2015
Device MODEL Number103
Device LOT Number202430
OTHER Device ID NumberVERSION 8.1
Was Device Available For Evaluation? No
Date Returned to Manufacturer07/10/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/10/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/04/2013
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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