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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 12/22/2011
Event Type  Malfunction  
Event Description

Additional information was received on (b)(4) 2012, where it was reported that there were no x-rays available to send to the manufacturer for review. There were no reports of trauma or manipulation. The relationship of the seizures to vns is unknown as well as the relationship of the seizures to vns as they did not detect any high lead impedance until the date of surgery. The patient was hospitalized due to the seizures and her medication was adjusted. The patient does have multiple types of seizures and all increased. It was difficult to assess whether any causal or contributory programming/medication changes or other external factors preceded the onset of the seizures. Product analysis of the explanted generator and lead was completed. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pins at one point in time. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Note that since a portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

 
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.

 
Event Description

It was initially reported that during prophylactic generator revision surgery on (b)(6) 2011, high lead impedance was obtained with the old generator and new generator therefore the lead was replaced. A company representative called back later and stated that originally, they thought the high lead impedance was due to the patient's output current being high (3. 5 ma) however with the new generator attached to the existing leads, high lead impedance was obtained therefore it was decided to replace the lead. The surgeon noticed that some of the helices did not appear to be attached to the nerve and were embedded. This portion of the lead was not removed as the surgeon did not feel it was safe to do so. Once the new lead and generator were implanted, the impedance value was 1350 ohms. Per the patient's mother, the patient started having more seizures (below baseline levels) and about a month ago, the patient had two grand mal seizures which had not occurred previously. The magnet also appeared to be less effective in aborting seizures. The explanted lead and generator were returned on 12/27/2011 and are currently undergoing device evaluation. Good faith attempts to obtain additional information have been unsuccessful to date. The patient¿s programming and device diagnostic history available in the in-house database were reviewed and no records of high lead impedance were found however the data was only available up to 12/07/2010.

 
Manufacturer Narrative

Analysis of programming and device diagnostic history performed. Device failure is suspected but cannot be confirmed.

 
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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
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2420397
Report Number1644487-2012-00149
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/22/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/18/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2010
Device MODEL Number302-20
Device LOT Number200419
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/27/2011
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/27/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/06/2007
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: 01/18/2012 Patient Sequence Number: 1
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