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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 01/10/2013
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported by the surgeon the patient was going to have her vns explanted on (b)(6) 2016. The surgeon stated the patient had been implanted for over 3 years and the vns was not effective because the patient wasn't able to tolerate titrating up the vns settings. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

It was later reported the patient had requested for the device to be explanted because she didn't like it and it wasn't helping her. It was noted the device was programmed off because the patient didn't like the current, but then she just didn't like the vns. There were no issues with the vns, the patient just did not like it and requested the explant. It was later verified the patient's vns was explanted on (b)(6) 2016.

 
Manufacturer Narrative

This information was inadvertently left off of the supplemental #01 mfr. Report. (b)(4).

 
Event Description

It was later reported by the same physician that the adverse events the patient experienced during titration included pain in the neck, difficulty swallowing, uncomfortable when the current is programmed on, increased falls during her seizures, and no decrease in seizures activity. It was also noted that the patient's seizures were possibly worse with vns; however, no actual seizure rates were given.

 
Event Description

It was reported by the explanting facility that the device was discarded.

 
Manufacturer Narrative

This information was inadvertently left off of supplemental #03 mfr. Report.

 
Event Description

It was initially reported by the explanting site that the vns devices had been discarded; however, additional information was received from the site and they had requested the return number so that they could send the generator back. The generator and a portion of the lead were returned to the manufacturer. While analysis is expected, it has not been completed to date.

 
Manufacturer Narrative

(b)(4).

 
Event Description

Product analysis (pa) for the returned generator was completed. The device performed per functional specifications. There were no performance or any other type of adverse conditions found with the generator. Pa for the returned lead was completed. Note that the lead assembly (body) including a portion of the connector boot; therefore, a complete evaluation could not be performed on the entire lead product. The condition of the returned portion of the lead was consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted.

 
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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 Key6181099
Report Number1644487-2016-02892
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/07/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/16/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2014
Device MODEL Number103
Device LOT Number202155
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/10/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Device Age4 yr
Event Location Other
Date Manufacturer Received04/12/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/13/2012
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: 12/16/2016 Patient Sequence Number: 1
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