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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
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/01/2017
Event Type  Injury  
Manufacturer Narrative

 
Event Description

Clinic notes were received for generator replacement referral. Per notes, the patient reported that she feels her vns has been more painful lately, and wonders if it is not working any longer. At the previous clinic visit, she mentioned that her vns was not firing off for a couple hours (normally, she can feel it firing). It was reported to be working ok since then up until past two weeks, when she has been feeling pain in her left chest area, under her armpit, especially when the device fires. Patient also feels a wire present near the attachment to the device which was not noticeable to her previously. Patient has not had any injuries or falls which may have damaged the device. Patient compares this to a similar feeling she had before the batter was replaced previously. Patient's device was interrogated but no adjustments were made. The patient consulted with a surgeon who indicated that a generator replacement is recommended. The lead impedance was normal and so lead replacement is not needed. Impedance - 2424 ohms. The surgeon noted granulation tissue or lead wire close to the skin in the chest area. The incision was however well healed. No other relevant information was received. No known surgical interventions have occurred to date.

 
Event Description

Additional information was received that the surgery was for patient comfort. There were no causal or contributing factors that preceded the painful stimulation and the report of erratic stimulation. The reported protrusion was confirmed invalid and thought to be patient's perception. There was no wires on exam like reported. Patient's settings were provided but diagnostics were not. The patient underwent generator replacement surgery. The explanted device was discarded.

 
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Brand NamePULSE GEN MODEL 103
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 Key6949677
Report Number1644487-2017-04601
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 11/14/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/13/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/27/2014
Device MODEL Number103
Device LOT Number3495
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/26/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/19/2012
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: 10/13/2017 Patient Sequence Number: 1
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