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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. 102 GENERATOR

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CYBERONICS, INC. 102 GENERATOR Back to Search Results
Model Number 102
Event Date 05/28/2014
Event Type  Injury  
Event Description

It was reported that following generator replacement surgery, the patient had an infection at the generator site within approximately twenty days of the replacement surgery. An additional surgery was performed to move the generator out of the infected pocket and to a new site on the patient¿s right side.

 
Event Description

It was reported that the patient underwent explant due to infection. The physician noticed redness following the path of the lead and decided to explant.

 
Manufacturer Narrative

 
Manufacturer Narrative

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

 
Manufacturer Narrative

 
Event Description

It was reported that the patient underwent vns reimplant on (b)(6) 2014.

 
Event Description

It was reported that the infection was caused by skin contaminant. The infection has resolved and reimplant will occur in the future.

 
Manufacturer Narrative

Corrected data: this information was inadvertently reported incorrectly on follow-up mfr. Report #01.

 
Event Description

Product information was obtained.

 
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Brand Name102
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 Key3937896
Report Number1644487-2014-01767
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/17/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/16/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2015
Device MODEL Number102
Device LOT Number202614
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/12/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 07/16/2014 Patient Sequence Number: 1
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