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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
Device Problem Insufficient Information
Event Date 06/22/2006
Event Type  Malfunction  
Event Description

It was reported by the patient that his vns had been "non-functional" for a few years and was no longer working. A battery life calculation was performed, which did not support battery depletion as a cause of the device being "non-functional. " the patient requested to have his device explanted. Programming history showed that diagnostics were within normal limits throughout the available history. The patient's device was programmed to relatively low settings. Attempts for further information were unsuccessful to date. No surgical intervention has occurred to date.

 
Manufacturer Narrative

Device available for evaluation, corrected data: the initial report inadvertently did not report that the devices were received. (b)(4).

 
Event Description

Clarification was received that the device being "non-functional" was actually lack of efficacy. The patient had explant surgery because she needed to have an mri performed, and the generator and lead were received for analysis. Analysis on the generator was approved. 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 device performed according to functional specifications. Analysis concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. Analysis on the lead has not been approved to date.

 
Event Description

Analysis on the lead was approved. Note that a portion of the lead assembly (body) including the electrodes was not available for analysis, and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portions was consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The set screw marks found on the lead connector pin provided evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed with no discontinuities identified. There was no evidence to suggest an anomaly with the returned portions of the device.

 
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Brand NamePULSE GEN MODEL 102
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 Key6610142
Report Number1644487-2017-03911
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 07/26/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/02/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/11/2007
Device MODEL Number102
Device LOT Number013894
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/01/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/17/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/05/2005
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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