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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 03/01/2013
Event Type  Injury  
Event Description

It was reported that since an increase in device settings from 1ma to 1. 25ma, the patient has been experiencing shocking sensations with device stimulation at night. It was reported that diagnostic testing performed on (b)(6) 2013 showed ok impedance (dc dc code 2). The patient indicated that the shocking sensation is more noticed when his head is turned a certain way. The patient requested that his device be programmed off which was done per his request. It was reported that the patient denies any trauma that may have contributed to the high impedance reading; however, the physician's assistant reported that the patient may not be completely honest. It was reported that the physician's assistant wanted the patient to go for x-rays; however, the patient declined. It was reported that the patient will be seen again in a couple of months and that at that time, it will be determined whether or not the device will be programmed back on.

 
Event Description

The physician's nurse indicated that the patient has no follow-up appointments scheduled at this time. The nurse suspects that the patient will begin to experience an increase in seizures with the device programmed off and will likely call and schedule an appointment. It was reported that the patient is only seen about once a year. No further information has been provided.

 
Event Description

It was reported that the patient's generator was turned back on since the previous report. No additional pertinent information has been received to date.

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
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 Key3290033
Report Number1644487-2013-02423
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/22/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/15/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2013
Device MODEL Number102
Device LOT Number3119
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/20/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/03/2011
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: 08/15/2013 Patient Sequence Number: 1
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