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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 Date 12/01/2014
Event Type  Injury  
Event Description

It was reported through clinic notes dated (b)(6) 2014 that the vns device has moved and is causing the patient pain. It was noted that this happened when her sister did chest compressions after a seizure. The generator is now down into the left breast tissue. Diagnostics showed the device was fine, with eos=yes. The patient had not had an increase in seizures and the physician felt that the patient having chest compressions was unnecessary and inappropriate and did cause the device migration. Although surgery is likely, it has not occurred to date.

 
Event Description

It was reported that the patient underwent generator replacement on (b)(6) 2015.

 
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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 Key4383816
Report Number1644487-2015-03525
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 12/11/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/06/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2007
Device MODEL Number102
Device LOT Number014007
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/03/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/16/2005
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: 01/06/2015 Patient Sequence Number: 1
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