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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 02/21/2011
Event Type  Injury  
Event Description

It was initially reported that the patient was experiencing an increase in his seizure frequency and intensity, characterized by multiple episodes of "blackouts" occurring between (b)(6) 2011. The physician attributed this increase to the generator nearing end of service; however, the diagnostics performed at the patient's appointment indicated that the device was not at end of service. The patient was scheduled for a generator replacement. Attempts for additional information from the neurologist have been unsuccessful to date. The generator was replaced on (b)(6) 2011. At that time, it was reported that the eri=yes flag had been observed. The device has not been returned to the manufacturer for product analysis.

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key2155925
Report Number1644487-2011-01468
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/01/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/30/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2003
Device MODEL Number102
Device LOT Number6559
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received06/01/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2002
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: 06/30/2011 Patient Sequence Number: 1
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