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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
Device Problem Unexpected Therapeutic Results
Event Date 04/01/2014
Event Type  Malfunction  
Event Description

It was reported that the vns patient was experiencing an increase in seizures and began having drop attacks which were reported to be a new seizure type for the patient. Magnet mode stimulation was also no longer effective in aborting the patient¿s seizures. It was noted that the patient¿s medications were being adjusted. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2010. A battery life calculation using the available programming history showed approximately 2. 6 years remaining. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

It was reported that the patient underwent vns lead and generator replacement on (b)(6) 2015. The reason for replacement was due to neos=yes and high impedance. The explanted lead and generator were received on (b)(6) 2015. Analysis of the lead is underway, but has not been completed to date. Analysis of the explanted generator was completed on (b)(6) 2015. The reported end-of-service allegation was not duplicated in the laboratory. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator.

 
Manufacturer Narrative

Review of the available programming and diagnostic history.

 
Event Description

Analysis of the explanted lead was completed on (b)(6) 2015. The reported allegation of high impedance was confirmed. Discontinuity of both the positive and negative quadfilar coils in the body region of the returned lead portions was observed. Abraded openings of both outer and inner tubing near the break locations were observed as well.

 
Manufacturer Narrative

Describe event or problem, corrected data: the supplemental report #2 inadvertently did not report the fluid leaks.

 
Event Description

The abraded openings and slice mark found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing.

 
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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 Key4719016
Report Number1644487-2015-04524
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative,COMPANY REPRESENTATI
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial,Followup,Followup,Followup
Report Date 04/01/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/22/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2001
Device MODEL Number300-20
Device LOT Number21619C
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/25/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/10/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/14/1999
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: 04/22/2015 Patient Sequence Number: 1
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