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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 01/06/2013
Event Type  Injury  
Event Description

New information was received which revealed that the generator was discarded. It was also noted that the patient's increase in seizures occurred when the vns generator was at end of service.

 
Event Description

It was reported that the patient have had increase in seizures and new seizure types were noted. The physician noted the generator was at end of service, but it is not known what indicator was seen. Additional attempts to contact the physician for additional information are underway. Attempts for return of the vns generator are in progress.

 
Manufacturer Narrative

 
Event Description

An implant card was received on (b)(6) 2013 stating that the generator was explanted due to battery depletion. The generator was replaced with an m105 on (b)(6) 2013. Lead impedance was ok.

 
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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 Key2951038
Report Number1644487-2013-00347
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/11/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/08/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2011
Device MODEL Number103
Device LOT Number201114
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/06/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/09/2009
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: 02/08/2013 Patient Sequence Number: 1
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