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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 03/24/2011
Event Type  Malfunction  
Event Description

On (b)(6) 2011, a vns treating physician reported that the vns patient was presenting with high lead impedance from a systems diagnostic test that showed limit/high/7/no that day. The physician said that the patient doesn't know of any specific incident that could have resulted in a potential lead fracture. The physician was advised to disable the patient's device, which she did later in the appointment. She was then told that if the patient were to continue therapy, his lead would likely need to be replaced. The physician noted that recent diagnostics performed were within normal limits, but she didn't have the results in front of her. On (b)(6) 2011, the patient's spouse requested information on the coverage for explanting the patient's device due to the need for an mri. The patient's wife said, they have decided not to replace the device due to a device malfunction, which she said was a fracture. She then went on to explain that prior to the high lead impedance, the patient was experiencing pain the neck and some visual issues where he couldn't see very well. The visual issues were later determined to be the result of a stroke so the patient needed to be referred for an mri, but her understanding was that because, he had an implantable device, he could not get one. Just the pain in the neck was thought to be related to vns, not the patient's stroke. The patient had been referred for multiple cat scans, which did not show a stroke so far; now the family wants the vns removed so they can do an mri. She was told that an mri could be performed, but there are specific precautions listed in our labeling. The wife then said that the vns id card said they couldn't do mris, but when asked to verify that the statement is present, she confirmed it was not. She then changed it to it was the physician who also said that an mri could not be performed, so she was informed that an mri is possible with certain limitations, as they are performed regularly by mri facilities. She was also told that the device can remain implanted and is not required to be removed, just disabled. Since the device has not been explanted and x-rays have not been received, a lead fracture has not been confirmed as the cause for the patient's high impedance. The patient's physician reported that the patient had gone to the emergency room for the pain in the neck and that a ct and an angiogram were performed which showed nothing abnormal. The physician does not know where the pain is related to vns or not. It is not known whether, the patient will have the device removed or replaced. The physician said that they will discuss it during the patient's next appointment; the specific date of the patient's next appointment was unknown. The physician said that after the patient returned from the hospital, the patient noticed that he wasn't having any voice alteration with stimulation. The patient was worried that his device wasn't working since he could not perceive any voice alteration. The physician does not think that the pain is associated with stimulation because, the patient could not be receiving stimulation due to the high impedance since the device may not be able to deliver the full current. The patient used to always have voice alteration with stimulation but it was not serious and no interventions were ever taken. The patient denied any trauma or fall that could have caused this. The physician could not provide any more settings or diagnostics. Additional information regarding the next steps the patient and physician were going to take for the patient's high impedance and pain was requested. The physician reported that x-rays were taken on (b)(6) 2011 and that they showed no anomalies. However the x-rays were not sent to the manufacturer for review. If additional information is received, it will be reported.

 
Manufacturer Narrative

Device failure is suspected.

 
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Brand NameLEAD MODEL 302
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key2073724
Report Number1644487-2011-00797
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/24/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/13/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/09/2006
Device MODEL Number302-20
Device LOT Number010904
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/24/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2004
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: 04/13/2011 Patient Sequence Number: 1
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