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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 03/01/2014
Event Type  Injury  
Event Description

Clinic notes were received indicating that the vns patient may have experienced some sort of an axillary infection in (b)(6) 2014 from poking and scratching at his device. The patient¿s device was reported to be functioning well at the time. Attempts for additional relevant information have been unsuccessful to date.

 
Manufacturer Narrative

 
Event Description

Clinic notes dated (b)(6) 2014 reported that the patient had been treated for an ¿abscess¿ in the left axillae with an incision and drainage by his primary care physician on two occasions recently. The most recent was about a week and a half prior. The patient denied any antibiotic prescription given. The patient reported that it had returned somewhat. Upon physical examination, there was an approximate 1. 5 inch length palpable lesion in the left axillae which was soft but not mobile. There was no redness or skin breakdown. There was no tenderness to palpitation. The physician¿s assessment at that time was that the lesion may represent a sterile cyst versus infection abscess with the infection abscess less likely. Clinic notes dated (b)(6) 2014 reported that the patient had an axillary cyst which had since been drained and appeared to have improved at that point.

 
Manufacturer Narrative

Manufacturer device history records were reviewed. Review of the generator device history records confirmed sterilization was performed prior to distribution.

 
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Brand NamePULSE GEN MODEL 102
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 Key3882083
Report Number1644487-2014-01529
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/20/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/18/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2014
Device MODEL Number102
Device LOT Number3492
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/03/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/13/2012
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: 06/18/2014 Patient Sequence Number: 1
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