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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 101

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CYBERONICS, INC. PULSE GEN MODEL 101 Back to Search Results
Model Number 101
Event Date 05/18/2001
Event Type  Injury  
Event Description

Clinic notes were received for review. It was reported that this patient's device was at end of battery life. Clinic notes dated (b)(6) 2013: "he had a vagus nerve stimulator placed in 2003 or so and developed an upper gi bleed from recurrent retching. Endoscopy has revealed a hiatal hernia. " the relationship of this to their implant is unknown good faith attempts are underway for further details. The patient's father called and reported that the patient aspirated on (b)(6) and was in the icu, intubated, and discharged on (b)(6). The patient has left side weakness as a result of previous epilepsy surgery. The patient's father is an ent physician from another country, and states the aspiration was not caused by their vns but the patient's other co-morbidities. He reported that the patient was unable to tolerate increases in vns dosing over the years, causes "retching", since vns was placed in 2001. He does not believe that patient has received "much benefit" but feels that should have replacement as there are no other options left to him.

 
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Brand NamePULSE GEN MODEL 101
Type of DevicePULSE GEN MODEL 101
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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3075317
Report Number1644487-2013-01109
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/28/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/24/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2002
Device MODEL Number101
Device LOT Number2525
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/01/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/22/2001
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: 04/24/2013 Patient Sequence Number: 1
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