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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105

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CYBERONICS, INC. PULSE GEN MODEL 105 Back to Search Results
Model Number 105
Event Date 07/03/2012
Event Type  Injury  
Event Description

It was reported that a vns patient had their device explanted for infection. Their infection was first noticed on (b)(6) 2012. The patient was placed on iv antibiotics and later oral antibiotics. Since removal of their vns generator their infection has resolved. There are no plans to reimplant the patient with another vns system. The patient a grand mal seizure and that is what caused their generator site to open and become infected. It was red,swollen, draining and smelling. Skin and blood cultures were negative but an obvious infection was present in ther generator pocket.

 
Event Description

The patient's generator was returned for analysis. Results of diagnostic testing indicated the device was operating properly. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator.

 
Event Description

An implant card was received indicating that the vns patient was re-implanted with a new generator and lead on (b)(6) 2014.

 
Manufacturer Narrative

Date received by manufacturer (mo/day/yr) on supplemental report 01 should have been (b)(4) 2012, not 2015.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

Corrected data: device manufacturing records were reviewed for the patient's lead. Review of manufacturing records confirmed sterilization for the lead prior to distribution.

 
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Brand NamePULSE GEN MODEL 105
Type of DevicePULSE GEN MODEL 105
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 Key2676148
Report Number1644487-2012-01925
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 07/09/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/31/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2014
Device MODEL Number105
Device LOT Number201019
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/11/2012
Is The Reporter A Health Professional? Yes
Distributor Facility Aware Date08/24/2012
Event Location Other
Date Manufacturer Received06/18/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/07/2012
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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