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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS PULSE GEN MODEL UNK GENERATOR

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CYBERONICS PULSE GEN MODEL UNK GENERATOR Back to Search Results
Model Number 10X
Event Date 12/29/2012
Event Type  Injury  
Event Description

On (b)(6) 2013, it was reported that this vns patient had shown symptoms of autoimmune process which is appeared with subfebrile temperature, pains in joints etc, but the locus with generator is absolutely intact. The event began on (b)(6) 2012. The symptoms included high temperature, pain in the right knee and left elbow joints while moving, and swollen, hot joints. The patient was hospitalized with anti-inflammatory therapy. The antibiotics were applied successfully, and the patient left the clinic. The high temperature and pain began again on (b)(6) 2013. The locus of generator was intact. Anti-inflammatory therapy was continued. The number of seizures was increased almost to the pre-vns baseline (after vns implant, the patient experienced a 50% seizure elimination). Doctors did not determine the clear causes of the situation, but pediatricians tended to relate it to vns. The patient's heredity is free of distinctive features. The mix of antiepileptic drugs and vns parameters were not modified. The previous week, the patient left the clinic with satisfied status. The diagnosis was juvenile rheumatoid polyarthritis. The rheumatoid tests are negative. Cytostatics are not prescribed because the diagnosis is disputable. The generator was never disabled. No diagnostics are available.

 
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Brand NamePULSE GEN MODEL UNK
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS
100 cyberonics blvd
houston TX 77058
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 Key2976156
Report Number1644487-2013-00497
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/26/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/25/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number10X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/26/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 02/25/2013 Patient Sequence Number: 1
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