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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 05/01/2012
Event Type  Injury  
Event Description

It was reported on (b)(6) 2012, that a vns patient would be referred for generator revision surgery as the patient is at high settings, rapid cycling, and the patient' s family wanted to have it replaced prior to a trip they were taking in (b)(6). On (b)(6) 2012, clinic notes were received dated (b)(6) 2012 where it stated that the patient was diagnosed with complex partial seizures. The last seizure occurred on (b)(6) 2012 and was said to be less than 1 minute in duration. The patient's parents stated that the seizure have increased in frequency and duration over the last few weeks despite the patient being compliant with medications. The patient will intermittently appear blue or cold. The device was found to be set to 2. 5/20/250/21/1. 1/2. 75/250/60. The patient's dosage of sabril was increased from 2 tablets to 3 tablets and the patient was referred for generator revision surgery. Good faith attempts to obtain additional information have been unsuccessful to date however it is known that the patient is scheduled for generator revision surgery later next month ((b)(6) 2012).

 
Event Description

Analysis of the generator has been completed. The generator performed to specifications and no anomalies were found.

 
Manufacturer Narrative

 
Event Description

Additional information was received indicating the patient's generator had been replaced. The explanted generator was returned and is currently undergoing analysis.

 
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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 herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2619580
Report Number1644487-2012-01531
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/31/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/18/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2007
Device MODEL Number102R
Device LOT Number013834
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/18/2012
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/13/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/25/2005
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: 06/18/2012 Patient Sequence Number: 1
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