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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Event Date 07/29/2014
Event Type  Injury  
Event Description

It was reported that the vns patient¿s neck incision site dehisced and exposed the lead on (b)(6) 2014. The patient underwent surgery on (b)(6) 2014 to close the incision site and no signs of infection were observed at the time. On (b)(6) 2014, the patient presented with a small amount of pus from the incision site and was subsequently treated with an antibiotic regiment. Cultures were positive for staph aureus. It was noted that the patient did not take proper care of her incision sites and was noncompliant in keeping her appointments. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

 
Event Description

It was reported on 01/19/2015 that the patient¿s lead and generator were explanted on (b)(6) 2015 due to infection. The patient was not re-implanted at this time. The lead and generator were returned for analysis on 01/21/2015. Product analysis was completed for the lead on 02/09/2015. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portions. Since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Product analysis was completed and approved for the generator on 02/17/2015. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 3. 034 volts as measured during completion of test parameter of the final electrical test, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

 
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Brand NameLEAD MODEL 304
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 Key4353667
Report Number1644487-2014-03445
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 11/24/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/22/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2017
Device MODEL Number304-20
Device LOT Number3815
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/21/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/19/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/06/2013
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: 12/22/2014 Patient Sequence Number: 1
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