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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 01/14/2014
Event Type  Injury  
Event Description

It was reported that the recently implanted vns patient underwent surgery to explant her device on (b)(6) 2014. High levels of serous secretion and signs of infection were observed at the generator site with 50% wound dehiscence. There were no signs of trauma at the generator site. The generator site had not improved since implant so the patient¿s device was explanted. The generator pocket was washed out with antibiotics following generator explant. One of the electrodes could not be explanted due to fibrosis which the physician attributed to vns. The remaining portion of the lead was explanted and the wound was washed out with antibiotics. Cultures were (b)(6) and the patient was given an antibiotic regiment. Further follow-up revealed that the infection developed at the generator site approximately three month following implant surgery. The patient is not expected to be re-implanted. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

 
Event Description

The patient was discharged in (b)(6) 2014 because the infection was resolved.

 
Manufacturer Narrative

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

 
Event Description

The lead and generator were returned for analysis on 02/27/2015. Product analysis for the lead was completed on 03/18/2015. Since a significant 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. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Product analysis for the generator was completed and approved on 03/24/2015. Potential contributing factors to the infection have been considered / evaluated and none were found to exist in this situation. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 3. 023 volts as measured during completion 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.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
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 Key3899763
Report Number1644487-2014-01610
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/03/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/27/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2015
Device MODEL Number103
Device LOT Number3754
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/27/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/16/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/25/2013
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: 06/27/2014 Patient Sequence Number: 1
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