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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 06/20/2014
Event Type  Injury  
Event Description

Further follow-up revealed that the device was programmed off, so that the patient could undergo monitoring for the coughing. The device was subsequently programmed back on. The patient underwent device explant on (b)(6) 2015 at the request of the patient¿s caregiver due to pain and dyspnea. The physician indicated that the surgeon would not have been performed had the caregiver not requested and the vns was functioning as intended. The explanted generator has not been received for analysis to date.

 
Event Description

It was reported that the patient's device was disabled due to uncontrollable coughing. It is unknown whether or programming the device off was to preclude a serious injury. Attempts to obtain 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 Key4698038
Report Number1644487-2015-04472
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/19/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/16/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2011
Device MODEL Number103
Device LOT Number2429
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/06/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/11/2009
Is The Device Single Use? Yes
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/16/2015 Patient Sequence Number: 1
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