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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 12/01/2012
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

It was reported that the patient's vns lead had experienced a fracture. It was not made apparent how the initial reporter determined there was a fracture problem. The device was reportedly disabled in (b)(6) 2012 in relation to this issue. Surgical intervention has not occurred to date. Attempts for additional pertinent information have been unsuccessful to date.

 
Manufacturer Narrative

 
Event Description

It was reported that the patient's explanted generator was discarded following surgery. No additional pertinent information has been received to date.

 
Event Description

Follow up attempts with the treating physician showed that although a lead break was suspected, it was never confirmed. X-ray images according to the treating physician showed no visible fracture. The vns was reported to have been "interrogated" few times with no abnormal results. The patient complained of pain at the time of the device disablement. The pain was occurring in the area of the left axilla and radiated into the upper left chest and neck, and did not coincide with stimulation. The patient's generator was explanted on (b)(6) 2016. The device has not been returned to the manufacturer to date. No additional pertinent information has been received to date.

 
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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 Key5697512
Report Number1644487-2016-01222
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Followup,Followup
Report Date 05/09/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/03/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2003
Device MODEL Number300-20
Device LOT Number1934
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/17/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/16/2001
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: 06/03/2016 Patient Sequence Number: 1
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