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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 10/24/2012
Event Type  Injury  
Event Description

It was later reported on (b)(6) 2013, that the vns patient had passed away on (b)(6) 2013 (death reported on mfr. Report # 1644487-2013-00234). It was stated that she had previously had the vns removed because it had come open and there was a possible infection.

 
Event Description

On (b)(6) 2012 it was reported that the vns patient was having an issue with her wound closing. It was later reported that the patient was admitted for gi issues and someone said that they could see the patient's vns device. The patient was noted to often use restraint type straps in a stroller. It was later reported that the surgeon decided to remove the patient's generator on (b)(6) 2012 as she believed the patient was picking at the site causing the problem with the wound healing. The surgeon stated that she would not put another vns in the patient due to her being a picker.

 
Manufacturer Narrative

 
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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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2836402
Report Number1644487-2012-03036
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/24/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/16/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2014
Device MODEL Number103
Device LOT Number202107
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/07/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/10/2012
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: 11/16/2012 Patient Sequence Number: 1
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