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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 103 Back to Search Results
Model Number 103
Event Date 05/18/2011
Event Type  Injury  
Event Description

A vns treating physician reported that they had a patient whose device lead and generator was explanted for a wound infection in the chest wall pocket. The patient had (b)(6) confirmed by cultures. No patient manipulation or trauma preceded the event. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

 
Event Description

Additional information was received that patient's vns generator was explanted on (b)(6) 2011, on (b)(6) 2012 the leads were explanted. The patient was not re-implanted with another generator or leads. Currently they are investigating possibly performing a right-sided vns implantation for this patient. No surgery is planned at this time.

 
Event Description

It has been decided not to reimplant the patient's vns. No right sided surgery planned.

 
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 NamePULSE GEN MODEL 103
Type of DevicePULSE GEN MODEL 103
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 herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2471136
Report Number1644487-2012-00533
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/15/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/28/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2013
Device MODEL Number103
Device LOT Number201694
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Distributor Facility Aware Date07/17/2012
Event Location Other
Date Manufacturer Received07/17/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/21/2011
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: 02/28/2012 Patient Sequence Number: 1
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