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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
Device Problem Insufficient Information
Event Date 07/21/2015
Event Type  Injury  
Event Description

A provider reported that a patient had experienced a new seizure type of greater than 10 minutes duration and that the patient was taken to the emergency room and hospitalized. It was reported that the patient had not experienced any seizures since the date of implant, (b)(6) 2015. Attempts for additional relevant information have been unsuccessful to date.

 
Manufacturer Narrative

(b)(4).

 
Event Description

Follow up with the treating facility indicates that the patient was discharged home from the emergency room and did not receive any medical intervention while in the emergency room. The patient was instructed to follow up with his neurologist. Available programming history and diagnostic data was reviewed and no anomalies were noted. Attempts for additional relevant information have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 103
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 Key4961275
Report Number1644487-2015-05396
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,COMPANY REPRESENTATIVE,HEA
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 07/21/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/03/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/23/2016
Device MODEL Number103
Device LOT Number203154
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/07/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/06/2014
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: 08/03/2015 Patient Sequence Number: 1
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