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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 05/22/2012
Event Type  Injury  
Event Description

Attempts for product return have been unsuccessful as it was reported by the hospital that the generator was not received for return following the surgery. Attempts to the treating physician have been unsuccessful to date. Additionally, it was noted on (b)(6) 2012, that the patient's generator had reached end of service and could no longer be interrogated. A review of available programming history revealed that diagnostics in may 2012 were within normal limits.

 
Manufacturer Narrative

Analysis of programming history performed. Describe event or problem: corrected data: it was inadvertently not reported on the initial report that the generator had reached end of service.

 
Event Description

On (b)(4) 2012 , the manufacturer received some of a vns patient's clinic notes from office visits dated (b)(6) 2012, and (b)(6) 2010. On (b)(6) 2010, it was indicated that the patient had four different seizure types. The first seizure was a generalized tonic-clonic type seizure usually occurred when the patient was sleeping with a frequency of 5-7 per month. The second type of seizure was myoclonic and occurred sporadically. The third type of seizure was starring episodes and the patient's caregiver has not noticed this type of seizures recently. The last type of seizure is atonic where the patient would suddenly drop to the floor. Her psychiatric parameters were reviewed and they appeared to be normal and the patient was negative to anhedonia. The vns device was interrogated and all settings appeared to be normal. There was no indication of a high lead impedance or a battery failure. On (b)(6) 2012, it was stated that the patient developed uncontrolled clinical semiology indicative of depression. This event is said to have occurred after the office visit on (b)(6) /2010, as there were no signs of any abnormal psychiatric behavior during that visit. The patient is not able to remember how to do basic activities such as controlling the temperature of water using a shower faucet. The frequency of her first type generalized tonic-clonic seizures was three during the last 30-40 days. The patient had increase starring episode compared to her previous office visit. There was no information about the myoclonic and atonic type of seizure indicated during the previous office visit. Interrogation results of the vns indicated no high lead impedance or battery failure. Per the physician's note, the patient is "rapidly approaching end of service based on her settings. " the notes also indicated that the patient has a medical history positive for anhedonia and the patient is oriented to time, place, person and situation. At that time the patient was being referred for a psychiatric consultation. On (b)(6) 2012, the patient's vns device was checked and the patient's mother thought the device was not working as the patient has started to have more frequent seizures in the last few months leading up to the appointment on (b)(6) 2012. The patient has 1-3 generalized grand tonic clonic seizures every week and occasional myoclonic seizures. There was no information provided on the starring episodes and atonic seizures. There was no psychiatric assessment of the patient and no information of depression indicated on clinic notes dated (b)(6) 2012. The patient was referred for and underwent revision on (b)(6) 2012. Attempts for additional information and product return are in progress.

 
Manufacturer Narrative

 
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Brand NamePULSE GEN MODEL 102
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 herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2904808
Report Number1644487-2013-00080
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/11/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/09/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2008
Device MODEL Number102
Device LOT Number016030
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/24/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/12/2006
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: 01/09/2013 Patient Sequence Number: 1
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