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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 01/28/2016
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported that the patient is scheduled for a prophylactic generator change and lead reposition. She has a left breast tumor that is also being removed at the same time. Good faith attempts to the physician for additional information regarding the tumor have been unsuccessful. Although surgery is likely, it has not occurred to date.

 
Event Description

On (b)(6) 2016 the patient had a prophylactic generator replacement. The surgery was done in conjunction with a left breast biopsy. The lead was tunneled and relocated to the right breast.

 
Manufacturer Narrative

Follow-up #, corrected data: supplemental #1 inadvertently had the follow-up # as blank and not selected.

 
Event Description

The patient was being referred for possible revision because she is getting ready to do radiation for breast cancer. She had previously had a tumor removed on her left breast. No additional relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
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 Key5450833
Report Number1644487-2016-00377
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 01/28/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/22/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/30/2010
Device MODEL Number102
Device LOT Number200880
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received04/22/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/03/2008
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: 02/22/2016 Patient Sequence Number: 1
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