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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 07/15/2015
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

On (b)(6) 2015 it was reported that the patient has high impedance. Normal mode diagnostics were performed which showed a dcdc of 7 and output=limit. The patient also reported painful stimulation. His report of the location of pain varies, but it does appear to occur when the device turns on. He reported that it's in his neck, then his head, and then his chest. They didn't want to perform system diagnostics due to the patient's report of painful stimulation at settings lower than the system diagnostic test settings. It was also noted that the patient has voice alteration when the device cycled on. The vns device was left on at the patient's request. The patient was referred to a surgeon. Although surgery is likely, it has not occurred to date. The physician reported that no patient manipulation or trauma occurred. She noted that a ct scan had been performed on the patient but not x-rays.

 
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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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4959601
Report Number1644487-2015-05403
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation HEALTH PROFESSIONAL
Report Date 07/15/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/03/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2000
Device MODEL Number300-20
Device LOT Number18524C
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/15/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/03/1998
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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