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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 101 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 101 GENERATOR Back to Search Results
Model Number 101
Event Date 01/01/2007
Event Type  Injury  
Event Description

Follow-up with the implanting surgeon revealed that from the generator replacement in 2008 there was no mention of a suture being used in the operative note of use of suture to secure the generator to the fascia. Training was provided to the surgeon's office regarding labeling recommendations that a non-absorbable suture be used to secure the generator to prevent such occurrences of generator migration.

 
Manufacturer Narrative

Date received by manufacturer, corrected data: the supplemental report #1 inadvertently reported the date the information was received by the manufacturer incorrectly. The correct date field was (b)(4) 2012.

 
Event Description

It was reported that the patient was scheduled for vns explant due to an unknown reason. Upon further follow-up, the nurse at the treating physician's office reported on (b)(6) 2012 that the patient's device is being scheduled for explant because it was turned off some time ago for an unclear reason. She thought it may have been due to a low heart rate. Follow-up with the nurse revealed the patient had generator replacement on (b)(6) 2001, and on (b)(6) 2001, the patient was admitted to the hospital with low sodium of 120 on carbamazepine and levetiracetam. She was taken off carbamazepine, and was readmitted on (b)(6) 2001, with cognitive abnormalities on levetiracetam and phenytoin. She has a history of episodic tachycardia and is on betablocker since 2007. Patient was started on ltg in 2008, and the vns was turned off on (b)(6) 2008, due to tachycardia without underlying cause. Per the nurse, after having her device turned off for several years, the "episodic tachycardia remains unexplained, but she is taking a beta blocker". A note from the cardiologist dated (b)(6) 2008, stated that the patient's seizure medications were reduced and she had one significant seizure episode. Since then, she had more palpitations and some vague chest pain. Patient returned on this day for a follow-up due to recent increase frequency of palpitations. Patient had episodes of seizures about every two to three weeks, and it was noted that the patient had a vagal nerve stimulator placed. After the seizure episodes, the patient had palpitations usually at night and lasted for less than minutes, most consistent with probable premature beat feelings. The metoprolol sode was increased to "25 mg daily for pac or inappropriate sinus tachycardia suppression. She also had some vague chest pain and was initiated for cad evaluations. She also has some exertional fatigue. Otherwise, she denied any other cardiac-related complaints". Although surgery is likely, it has not occurred to date.

 
Manufacturer Narrative

 
Event Description

Additional follow up with the nurse was performed who reported that the details regarding the events are not remembered. The patient was complaining and being treated for tachycardia. The vns was turned off for an mri on (b)(6) 2008, and the patient had it turned back on (b)(6) 2008 reportedly. When trying to turn the output current on, the nurse reportedly "could not get the output past 0. 75ma" due to extreme coughing. Although the previous output current was 2. 0ma, the site attempted to turn the current to 1. 75ma but the patient experienced violent coughing. Current decreased to 1. 5ma with on time every 3 minutes and off time at 1. 8 minutes. The settings were not tolerated, and continued to not be tolerated at 1. 25ma. Current was therefore decreased. Due to the tachycardia, the vns was turned off soon after per the nurse (which was observed on (b)(6) 2008). Later on (b)(6) 2009, the notes indicated that the device had been turned off with no exacerbation of seizures over 6 months. Patient requested to have the device removed for reasons of pain and discomfort at night. Patient was referred for surgical consult for vns explant. Notes dated (b)(6) 2009 revealed that the patient requested to have vns removed, "as it has not been helping and is somewhat uncomfortable moving around in the pocket".

 
Manufacturer Narrative

Suspect medical device, lot number, expiration date, corrected data: the initial report did not report this product information at that time. Device manufacture date, corrected data: the initial report did not report the manufacturer date at that time.

 
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Brand NamePULSE GEN MODEL 101
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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2883274
Report Number1644487-2012-03441
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 12/04/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/21/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2002
Device MODEL Number101
Device LOT Number303
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/06/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/09/2000
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: 12/21/2012 Patient Sequence Number: 1
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