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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
Event Date 05/29/2014
Event Type  Injury  
Event Description

It was reported that the patient only underwent generator replacement. An implant card was received indicating that only the patient's generator was replaced. Attempts to obtain additional relevant information have been unsuccessful to date.

 
Event Description

Clinic notes were received for the vns patient¿s office visit with his neurologist on (b)(6) 2014. The notes indicate that the patient was recently experiencing an increase in seizures. The patient had four seizures in the past year which consisted of a blank stare, cyanosis around the lips, and a stiff dystonic posture. The notes also indicate that the patient¿s lead was protruding in the neck. The patient¿s device was tested and diagnostic results showed an ifi condition with normal device function. The device on-time was increased and the patient began experiencing significant bouts of coughing. Further follow-up revealed that the patient underwent generator replacement surgery on (b)(6) 2014. It is unclear if the patient¿s lead was revised or replaced during the procedure. The explanted generator has not been returned to date. 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 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 Key3902433
Report Number1644487-2014-01627
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/04/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/30/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2010
Device MODEL Number103
Device LOT Number200981
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/27/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/11/2008
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: 06/30/2014 Patient Sequence Number: 1
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