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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
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2011
Event Type  Injury  
Event Description

Clinic notes were received in regards to a vns explant referral. Within the clinic notes it was stated the patient is interested in having her vns removed. It was noted the vns had been programmed off since 2011, but the patient continues to have physical discomfort. Attempts for additional relevant information have been unsuccessful to date. No known surgical interventions have occurred to date.

 
Event Description

Additional information was received that the patient's pain after disablement is suspected to be at the generator site. The cause of the pain remains unclear. Both the generator and as much of the lead as possible will be removed. The removal is for patient comfort and to improve quality of mri to evaluate for breast cancer. The breast cancer was not reported as an allegation against vns therapy. Per notes, patient has a family history of breast cancer and is going for mri screening for breast cancer. Patient also experienced pain at generator site. The painful stimulation in the chest occurred after patient had gastric bypass surgery when vns was turned back on. No known surgical interventions have occurred to date.

 
Manufacturer Narrative

Report source, corrected data: health professional and company representative. Supplemental mdr #2 inadvertently did not include the report source. Date received by manufacturer, corrected data: 03/02/2018. Supplemental mdr #2 inadvertently did not include the date received by manufacturer.

 
Event Description

Patient underwent explant surgery to remove the vns. Explanted devices will not be returned per hospital policy.

 
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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 Key6551029
Report Number1644487-2017-03735
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 03/27/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/08/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2013
Device MODEL Number102
Device LOT Number201956
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/29/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/28/2011
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: 05/08/2017 Patient Sequence Number: 1
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