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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 04/08/2014
Event Type  Malfunction  
Event Description

It was reported that a vns patient received a high impedance warning during diagnostic testing and that the patient¿s generator was disabled as a result. Last successful diagnostic results were reportedly obtained seven (7) months earlier. Surgery has not occurred to date.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
Event Description

On (b)(6) 2014 it was reported that the generator and lead would be returned for product analysis. A full revision surgery had taken place on (b)(6) 2014 due to the high impedance. The generator and lead were received for product analysis on (b)(4) 2014. Product analysis is still underway and has not yet been completed.

 
Manufacturer Narrative

Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

 
Event Description

On august 18, 2014 product analysis was completed on the explanted generator. Results of diagnostic testing indicated that the battery status indicated ifi=no in the product analysis lab. The battery voltage was 2. 895 volts (not at ifi) as measured during completion of the final electrical test. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. The review of the device's internal memory showed the impedance went from 9799ohms to 12299ohms on (b)(6) 2014, both of which are high impedance. Product analysis was completed on the lead on 9/2/14. Except for slight observed pitting on the negative connector pin and one abraded outer tubing observation, there were no observed product related issues with the returned lead portions. Scanning electron microscopy images of the unmarked connector pin show that pitting or electro-etching conditions have occurred on the connector pin surface at the areas where reddish-brown deposits were noted. An energy dispersive spectrometry (eds) analysis performed on the sample of the reddish-brown deposits observed on the pin showed the presence of some elements typically observed on stainless steel 316/316l. The higher percentage of iron observed in this sample suggests that an oxidation process may have occurred. The exact impact of this condition on any on the reported "high impedance" allegation is unknown. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. The outer silicone tubing is abraded open and the lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing of the second portion of the returned lead. No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portion.

 
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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 Key3786843
Report Number1644487-2014-01159
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/08/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/02/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2004
Device MODEL Number300-20
Device LOT Number6055
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/24/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/18/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/15/2002
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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