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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 101 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 101 GENERATOR Back to Search Results
Model Number 101
Event Date 01/01/2006
Event Type  Injury  
Manufacturer Narrative

 
Event Description

Clinic notes dated (b)(6) 2016 noted that the patient's device had to be programmed off due to aspiration after vns implant. The patient underwent peg tube placement as a result of the aspiration. Review of in house programming history identified that the vns was programmed off on (b)(6) 2006 and there is no history available indicating the device was turned back on. Further follow up with the patient's current treating neurologist identified that the aspiration has resolved and the peg was removed. The patient is now swallowing and breathing normally. The physician plans to program the device back on and titrate slowly to determine if the patient can now tolerate the vns. Attempts to obtain additional relevant information from the patient's previous treating neurologist and implanting surgeon have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 101
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key5430731
Report Number1644487-2016-00283
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 01/20/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/11/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2003
Device MODEL Number101
Device LOT Number5498
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/20/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/13/2002
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: 02/11/2016 Patient Sequence Number: 1
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