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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102R

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CYBERONICS, INC. PULSE GEN MODEL 102R Back to Search Results
Model Number 102R
Event Date 01/01/2007
Event Type  Injury  
Event Description

It was reported that the physician does not have any further information on the drop attack seizures that the patient experienced in 2007.

 
Event Description

Clinic notes were received for review that report that the patient was having a new seizure type identified as drop attack seizure on (b)(6). Good faith attempts are underway for further details about the reported event. At the time of this reported event their generator was not at end of battery life. They have had this battery replaced and it was returned for analysis. Generator eos was confirmed based on the measured battery voltage. The ¿as received¿ settings indicated a 58% duty cycle. Based on module performance according to the functional specifications. The unit exhibited current consumption rates that are within specification, thereby demonstrating normal battery depletion. No condition was noted during the product analysis evaluation that would suggest any anomaly with the device.

 
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Brand NamePULSE GEN MODEL 102R
Type of DevicePULSE GEN MODEL 102R
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 Key3174676
Report Number1644487-2013-01811
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/21/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/18/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2007
Device MODEL Number102R
Device LOT Number12991
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/07/2010
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/20/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/07/2005
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: 06/18/2013 Patient Sequence Number: 1
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