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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102R GENERATOR Back to Search Results
Model Number 102R
Event Date 06/22/2011
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was initially reported that the patient had generator replacement due to end of service (eri=yes). The generator was returned to the manufacturer for evaluation. The generator performed according to functional specifications. No eri flags were observed during testing. The device was continuously monitored for 24. 5 hours. The programmed output current measured within limits and showed no signs of variation. Diagnostic values were as expected for the programmed settings. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. A form that was return to the manufacturer reported that the replacement was prophylactic and patient was having seizures, no mention of if it was actually an increase in seizures. The seizures were initially believed to be related to the generator being at end of service but product analysis confirmed that it was not at end of service. Good faith attempt for more information have been unsuccessful to date.

 
Event Description

Additional information was received regarding the patient. The patient was having an increase in seizures and was hospitalized. Diagnostics were run and were within normal limits but clinically the patient was doing poorly. Since the generator replacement the patient is doing much better. The patient is at the same settings as prior to generator replacement except the off time was shorted to 1. 8 minutes. The patient has both complex and generalized tonic clinic seizures. It is unknown if the increase in seizures are above or below pre-vns baseline since the patient has been implanted with vns since 1999.

 
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Brand NamePULSE GEN MODEL 102R
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
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2261079
Report Number1644487-2011-02247
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/29/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/23/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date01/31/2009
Device MODEL Number102R
Device LOT Number016710
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/24/2011
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/26/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/28/2007
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: 09/23/2011 Patient Sequence Number: 1
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