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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 12/12/2014
Event Type  Malfunction  
Event Description

It was reported that device diagnostics resulted in high impedance (>= 10,000 ohms). It was reported that device diagnostics on (b)(6) 2014 were within normal limits. The patient was referred for x-rays. An implant card was received indicating that the patient underwent generator and lead replacement due to lead discontinuity. The generator was replaced prophylactically. The explanted devices are expected to be returned for analysis, but have not been received to date.

 
Manufacturer Narrative

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

 
Event Description

The explanted devices were received by the manufacturer for analysis. Analysis of the returned lead portion confirmed discontinuity of positive quadfilar coil in the body region and abraded openings of both outer and inner tubing near the break location. The abraded openings found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. Pitting was observed on the coil surface. Analysis of the returned generator is currently underway.

 
Manufacturer Narrative

Device failure occurred, but did not cause or contribute to death or serious injury.

 
Event Description

Analysis of the returned generator was completed. Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery showed an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator.

 
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Brand NameBIPOL LEAD MODEL 300
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
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 Key4397282
Report Number1644487-2015-03568
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/12/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/08/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2003
Device MODEL Number300-20
Device LOT Number4137
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/08/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/09/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/24/2001
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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