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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC BIPOL LEAD MODEL 300

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CYBERONICS INC BIPOL LEAD MODEL 300 Back to Search Results
Model Number 300-20
Event Date 07/11/2012
Event Type  Malfunction  
Event Description

On (b)(6) 2012, high impedance was observed during system diagnostics for the vns patient. The patient stated that the last time she had been seen and had her vns checked was in 2003. The patient reported that since (b)(6) 2012, she has felt a sharp pain in the left side of her face and down the left side of her neck. She stated that it started happening every 15-20 minutes, then every 10 minutes, and now it is occurring every 5 minutes for 5-10 seconds each time. The patient didn't know if it occurred with stimulation as she doesn't typically feel the stimulation. She further indicated that there was no recent trauma or manipulation that occurred prior to (b)(6) 2012 that may have caused or contributed to the pain or high impedance. The patient later stated that the pain is on the left side of her neck, a shocking sensation, only when the device is interrogated (more intense) and she also felt it when running diagnostics. She stated that she does not feel this pain at all at any other time. It was then confirmed with the physician that the pain she had been feeling in her face previously was found to be unrelated to vns as it was due to her neuralgia, which is being treated separately. The physician's office stated that the patient's vns is turned off, and the patient doesn't want replacement surgery at this time.

 
Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
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Brand NameBIPOL LEAD MODEL 300
Type of DeviceLEAD
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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2741379
Report Number1644487-2012-02289
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/20/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/12/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2002
Device MODEL Number300-20
Device LOT Number33883C
Was Device Available For Evaluation? No
Event Location Other
Date Manufacturer Received08/20/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/22/2000
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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