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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 02/12/2013
Event Type  Malfunction  
Event Description

Clinic notes dated (b)(6) 2015 were received. The notes state that the patient reports breakthrough spells and seizures.

 
Manufacturer Narrative

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

 
Event Description

On (b)(6) 2015 programming history was reviewed, and high impedance was observed. On (b)(6) 2004 (adjusted date (b)(6) 2013) the device was interrogated and a system diagnostic was performed and resulted in high lead impedance. No further programming history is available.

 
Manufacturer Narrative

 
Event Description

Clinic notes received (b)(4) 2015 and dated (b)(6) 2015 state that the patient is being seen for vns surgery, possible battery replacement. Notes state that the device worked well for several years then ¿stopped. ¿ battery interrogated and battery is dead. The patient was seen to discuss replacing the vns generator and electrodes. The patient underwent a full replacement on (b)(6) 2015. The generator and lead were received on (b)(4) 2015. Analysis is underway but has not been completed to date.

 
Manufacturer Narrative

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

 
Event Description

Product analysis for the generator was completed and approved on 06/16/2015. The end of service condition was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation. The device performed according to functional specifications. Analysis of the generator in the product analysis lab concluded that no abnormal performance or any other type of adverse condition was found. Product analysis for the lead was completed and approved on 06/25/2015. The lead assembly was returned for analysis and a break was identified in the positive coil. Scanning electron microscopy images of the positive coil ends and strand segments found in the organic matter show that pitting or electro-etching conditions have occurred at the break locations. Also, images of the suspected positive coil mating end and some of the strand segments show what appears to be wear (flat surfaces) on the coil strands. An abrasion was noted on the connector boot. White deposits were noted at the end of the connector boot. Abrasions were noted on the outer silicone tubing at multiple locations. The outer silicone tubing has a compressed appearance at multiple locations. A portion of the lead assembly is covered with what appears to be organic matter. The inner silicone tubing of the negative coil is abraded. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

 
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Brand NameLEAD MODEL 302
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 Key4627813
Report Number1644487-2015-04214
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 02/23/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/24/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2006
Device MODEL Number302-20
Device LOT Number009894
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/28/2015
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received06/16/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/05/2004
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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