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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 304

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LIVANOVA USA, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Event Date 04/03/2014
Event Type  Injury  
Event Description

Additional information was received stating that the vns patient underwent lead replacement surgery on (b)(6) 2014. The patient¿s generator was not replaced. The explanted lead has not been returned to date. Further follow-up revealed that the patient¿s device was tested during an office visit on (b)(6) 014 and diagnostic results showed normal device function. The patient was concerned that there was a potential relationship between vns and the patient¿s acid reflux. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

Additional information was received stating that, despite normal diagnostic results, the vns patient¿s lead was replaced due to the patient¿s increase in seizures following the motor vehicle accident. Furthermore, it was reported that the patient did not have a history of acid reflux. The reported acid reflux is believed to be related not to stimulation but to the patient¿s psychosomatic issues. Lead replacement surgery occurred prior to the onset of the acid reflux.

 
Manufacturer Narrative

The previously submitted mdr inadvertently did not include information regarding the reason for lead replacement surgery and the patient¿s acid reflux. The previously submitted mdr inadvertently did not include that no device failure is believed to have occurred as diagnostic results showed normal device function.

 
Manufacturer Narrative

Corrected data: this date on follow-up mfr. Report #03 inadvertently reported the incorrect year. The date should have been reported as 07/28/2014. The report was not a late submission.

 
Event Description

Clinic notes were received indicating that the vns patient was in a car accident on (b)(6) 2014 and sustained a neck injury. The patient had neck pain and immediately had a seizure following the car accident. The patient had been seizure free for nearly a year prior to the car accident. The patient¿s device settings were increased during an office visit on (b)(6) 2014. The patient¿s neck pain worsened with stimulation. The patient began having head and ear pain. The patient also began experiencing voice hoarseness, occasional drooling, and head tilting with stimulation. (the patient pulled her neck toward her chest during device on-times. ) x-rays were taken and were reported by the physician to be unremarkable. The patient¿s device settings were decreased during an office visit on (b)(6) 2014. The patient subsequently had four generalized convulsions within 24 hours. The patient¿s device settings were increased during an office visit on (b)(6) 2014 and the patient was able to tolerate her adjusted device settings. The patient was referred for surgery but no known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

It was reported that the patient's symptoms resolved after lead replacement surgery.

 
Manufacturer Narrative

New information changes the suspect device.

 
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Brand NameLEAD MODEL 304
Type of DeviceLEAD
Manufacturer (Section D)
LIVANOVA USA, INC.
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
LIVANOVA USA, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
rachel kohn
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3854244
Report Number1644487-2014-01417
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative,COMPANY REPRESENTATI
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/20/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/06/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2016
Device MODEL Number304-20
Device LOT Number3429
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/28/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/28/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/13/2012
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: 06/06/2014 Patient Sequence Number: 1
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