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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 01/01/2007
Event Type  Injury  
Event Description

Additional info was received from the pt indicating she continued to have a hurting sensation in the neck area where the electrodes were. The pt indicated that the event had been occurring ever since vns implant and her implanting physician would not remove her electrodes. Further info from a company rep indicated the pt was scheduled to see a surgeon for explant consult. F/u was made with the surgeon's office and indicated the pt is scheduled to undergo vns generator removal surgery as the pt complains of pain at the generator site. The pt's device is off and pt wants it out. The surgeon's office indicated the surgery was to preclude a serious injury and had no additional info regarding the pt's treating neurologist. Additional info from the surgeon's office indicated the pt underwent generator removal surgery as scheduled. Good faith attempts to obtain the explanted generator have been unsuccessful to date.

 
Event Description

Additional information was received from the patient on 12/21/2017 that the vns would constantly hurt her in the chest and where the wires were in the neck. She stated it started shorting out years prior. After the battery died it was still hurting her until she had it removed. She stated there was too much scar tissue in the neck on the electrodes and could not be completely removed. Additional relevant information has not been received to-date.

 
Event Description

Follow-up from the physician provided that the vns had served the patient well but that the patient had other underlying issues and offered to remove her vns.

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS, INC.
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 Key1959461
Report Number1644487-2011-00003
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 02/20/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/06/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number102
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2018
Was Device Evaluated By Manufacturer? Yes
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: 01/06/2011 Patient Sequence Number: 1
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