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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 07/24/2014
Event Type  Injury  
Manufacturer Narrative

Corrected data: the initial mfr. Report inadvertently reported the event as both serious injury and malfunction; however, this should only have been reported as a serious injury.

 
Event Description

It was reported that the vns patient was experiencing intense pain in her neck. The patient¿s device was subsequently disabled; however, the patient continued to experience stabbing pains but less frequently than before disablement. X-rays were taken and the lead reportedly appeared to be ¿unwrapped from the nerve. ¿ the patient underwent generator and lead replacement surgery on (b)(6) 2014. The explanting facility discarded the explanted lead; therefore, no analysis can be performed.

 
Event Description

Additional information was received which stated the patient experienced neck pain prior to the revision surgery, even though the diagnostics were within limits. It was noted that when the lead was explanted fluid was found inside. After the revision surgery, the patient's neck pain didn't go away for the first few days after the surgery, but then it did resolve.

 
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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 Key4027949
Report Number1644487-2014-02075
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 07/24/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/21/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2002
Device MODEL Number300-20
Device LOT Number255
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/06/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/31/2000
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: 08/21/2014 Patient Sequence Number: 1
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