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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 11/01/2012
Event Type  Injury  
Event Description

Pa of the generator was completed and approved on (b)(6) 2013. The device was returned due to the reported allegation of increased seizures. Results of diagnostic testing and monitoring indicated the device was operating properly. Electrical test results showed that the pulse generator performed according to functional specifications. Visual inspection results revealed no external device abnormalities. There were no adverse functional, mechanical, or visual issues identified with the returned generator.

 
Manufacturer Narrative

 
Event Description

Clinic notes dated (b)(6) 2012 were received on (b)(6) 2012. The notes indicated that the patient had not had any seizures for close to two and half weeks, which was positive. The physician was hopeful that the patient would return to her previous level of control. Follow-up showed that the patient had experienced a slight increase in seizures prior to generator revision that took place on (b)(6) 2012. The physician believed that the event was not related to vns but might have been related to the battery getting low. The relation to the patient's pre-vns level seizure frequency was unknown, and the patient's seizure frequency was very inconsistent. The patient usually had staring spells, drop seizures and generalized tonic seizures. The patient underwent prophylactic generator revision on (b)(6) 2012. The generator was returned on (b)(6) 2012 and is currently undergoing product analysis. Clinic notes dated (b)(6) 2012 indicated the patient's settings and diagnostics from that date.

 
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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 herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2909938
Report Number1644487-2013-00124
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/12/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/11/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2011
Device MODEL Number103
Device LOT Number201079
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/04/2012
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/18/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/20/2009
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: 01/11/2013 Patient Sequence Number: 1
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