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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 12/13/2011
Event Type  Injury  
Event Description

It was reported that the patient was admitted to the hospital on (b)(6) 2011 due to a prolonged partial seizure that consisted of quick jerking of her head to the left. When the patient was in the er, these movements were not identified as seizures and they continued for over an hour after being given 20 mg of valium. The device was interrogated and found to be programmed to 1. 75/30/250/30/1. 8/2/250/60 and 1/3 of the battery was left. The output current was increased to 2 ma and the magnet output current to 2. 25 ma. The physician was also going to increase the dosage of rufinamide and see about different dosing strategies for the vns. Clinic notes dated (b)(6) 2011 stated the seizure frequency increased. In clinic notes dated (b)(6) 2011 stated that the patient had 6 seizures in 1 week which was unusual, however, it was being attributed to the dosage of lamictal. The patient began to experience another increase in seizure activity at the end of (b)(6) 2012 and the patient would be referred for generator replacement surgery. Good faith attempts to obtain additional information were unsuccessful.

 
Event Description

Additional information was received on (b)(6) 2012, when analysis of the returned generator was completed. The generator was found to be functioning as intended and the ifi (intensified follow-up indicator) was sent to yes. The data stored in the generator revealed that 84. 075% of the battery had been consumed and the voltage was 2. 791 suggesting a partially depleted battery however the generator could deliver the programmed settings.

 
Event Description

Additional information was received on (b)(6) 2012 when it was reported that the patient had the generator explanted and replaced prophylactically. The explanted generator has been returned to the manufacturer and is currently in product analysis. Device evaluation has not been completed at this time.

 
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Brand NamePULSE GEN MODEL 103
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 Key2498678
Report Number1644487-2012-00769
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/22/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/21/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2011
Device MODEL Number103
Device LOT Number2631
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/02/2012
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/03/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/08/2010
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: 03/21/2012 Patient Sequence Number: 1
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