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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 Type  Injury  
Event Description

On (b)(6) 2013, it was reported that the patient's seizures have gotten worse and the patient now has blackouts and questionable syncope. It has been a few years since the patient's vns has been interrogated and the physician stated that she wants the patient to get follow-up with a neurologist, but the patient cannot be seen as she has no insurance. The patient's identifying information was not provided by the physician. Attempts were made for additional information; however, they were unsuccessful. No other information has been received.

 
Event Description

Additional information was received with patient identifying information.

 
Event Description

Attempts for additional information have been unsuccessful.

 
Manufacturer Narrative

Sex, corrected data: previously submitted mdr inadvertently omitted the patient¿s gender.

 
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Brand NamePULSE GEN MODEL 102
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 Key3577589
Report Number1644487-2014-00248
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/19/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/15/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2007
Device MODEL Number102
Device LOT Number012081
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/16/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/21/2005
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: 01/15/2014 Patient Sequence Number: 1
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