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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Event Date 06/01/2012
Event Type  Injury  
Event Description

On (b)(4) 2013, it was reported that this patient wanted her device removed. The patient reported that she developed a blot clot in the left neck. She was informed by her surgeon that the she bled quite a bit in surgery and had to be transfused intraoperatively. Three days after implanted, the patient began to experience frequent chest pains, shortness of breath, and difficulty speaking. She reported that she saw a pulmonologist who performed a bronchoscopy and informed her that her left vocal cord is almost completely paralyzed and that he could see the lead next to the vocal cord. The patient was last seen on (b)(6) 2013 at which time her settings were adjusted. (increased settings have not affected her chest pain and shortness of breath adversely: it was no worse and no better. ) attempts for information have been unsuccessful. Surgery is likely and will be captured in mfr report #1644487-2013-01510. The patient had earlier reported that two days after her system was implanted she went to the hospital because she could not breathe or swallow. The patient was turned on one month later. The patient indicated that the swallowing issue was only occurring a couple of times per week and not necessarily coinciding with stimulation on times. The breathing issue occurred all of the time and was worse with stimulation. The patient also experienced painful magnet stimulation at the electrode site (magnet output current: 1. 0 ma). The patient also had incidents of pain at the generator site for the past two to three months. The patient did not experience any trauma. At the hospital, her vitals were noted to be fine and everything was okay. The patient¿s physician was unable to provide information as to the cause of the events. The patient also reported that a ct performed after surgery showed a blood clot at the lead site. Follow-up at a patient appointment in september showed that the pulsewidth and frequency were too high. Once the settings were adjusted, the patient was fine. Follow-up with the surgeon¿s office showed that the patient was seen for implant and again in (b)(6) for post-op follow-up and one more time in (b)(6), at which time she reported the pain and swallowing; however, these were determined to be only the result of the patient¿s settings. At the follow-up appointments, the patient was healing well without any complications. Follow-up with the neurologist showed that the patient was doing well and was seen in (b)(6)with no complaints. The patient was doing well with seizure control. The relationship of the blood clot to vns was unknown. The patient was on clonazepam, lamictal, keppra, lamotrigine, haproen, and vimpat at the time of the event. No causal or contributory medication changes precede the onset of the thrombosis. To the physician¿s knowledge, the patient did not have a medical history of thrombosis, and there were no pre/co existing medical conditions which may have contributed to the event. No medical interventions were taken. The patient was last seen on (b)(6) 2012, and reported no new symptoms or issues.

 
Event Description

Additional information was received stating that the vns patient was hospitalized for several days due to shortness of breath. The patient was admitted to the hospital on (b)(6) 2014. The patient reported experiencing pain at her generator site while hospitalized but states that the pain had since resolved. The patient was also having seizures frequently. While hospitalized, the patient¿s device was found to be disabled. The neurologist at the hospital stated that the patient was suffering from depression and was taking too many aeds. Further follow-up revealed that the patient was seen by her following neurologist. The patient reported that her device had been disabled for two months prior to the office visit and that she was experiencing pain. The neurologist did not believe the pain was related to vns as the pain was not occurring at the patient¿s implant sites. After her office visit, the patient went to the emergency room due to a seizure on the bus that caused facial lacerations.

 
Event Description

On (b)(6) 2013, this patient reported that she was experiencing pain just above the generator site (related to the previous chest pain) and that she had been to the er numerous times for this discomfort. The pains reportedly began one week prior. The patient also indicated that this was in addition to the breathing problems and chest pains that began with vns implant. When the patient was at the hospital, x-rays were taken with no noted issues, and there was no infection. The patient was given pain medication. The patient noted that the device was previously turned off. This morning the settings were turned down, and the issues did seem to improve. Attempts for additional information have been unsuccessful.

 
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Brand NameLEAD MODEL 304
Type of DeviceLEAD
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3122977
Report Number1644487-2013-01474
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation PATIENT
Type of Report Initial,Followup,Followup
Report Date 05/07/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/21/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/29/2016
Device MODEL Number304-20
Device LOT Number202017
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received04/21/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/06/2012
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: 05/21/2013 Patient Sequence Number: 1
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