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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102R Back to Search Results
Model Number 102R
Event Date 08/02/2012
Event Type  Injury  
Event Description

Clinic notes were received for review prior to a patient going for a prophylactic generator replacement. Clinic notes dated (b)(6) 2012 were received. Reported was that she has unknown seizure frequency, but overall her parents think that they get the sense that her seizures are unchanged or possibly worsened since she was last seen in the clinic. She had increased output on the vns when she was last seen (b)(6) two weeks ago, she had some event reported to the family from the nursing home staff, which were concerning for apneic spells. Were told by the nursing home staff that she suddenly appeared to be "out of it"; and would slump over as if she were unresponsive or asleep. At the time she appeared to be turning bluish, and this resolved. She seemed to arouse when she was laid down flat. It was felt that these were not likely epileptiform events. She has a history of apneic spells in the past and does have obstructive sleep apnea per her parents reports. These event have not recurred since that time and she otherwise has been stable. The patient's vimpat was increased and her parents feel like her seizures may be worsening on this. Good faith attempts have been made and thus far no further information has been attained.

 
Manufacturer Narrative

 
Event Description

Product analysis was completed on the explanted generator. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. No further information has been received in regards to the patient's reported events.

 
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Brand NamePULSE GEN MODEL 102R
Type of DevicePULSE GEN MODEL 102R
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 Key2745363
Report Number1644487-2012-02333
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/17/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/14/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2009
Device MODEL Number102R
Device LOT Number1940
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/06/2012
Is The Reporter A Health Professional? Yes
Distributor Facility Aware Date08/17/2012
Event Location Other
Date Manufacturer Received11/08/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/23/2007
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: 09/14/2012 Patient Sequence Number: 1
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