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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 06/06/2013
Event Type  Injury  
Event Description

It was initially reported that the patient¿s oxygen saturation decrease during sleep to 83-84%. The casual relationship between vns stimulation unknown. Attempts for additional information have been unsuccessful.

 
Manufacturer Narrative

 
Event Description

Additional information was received that the relationship of the oxygen saturation drop at night to vns is unknown. The physician coordinated a dosage of risperdal and potassium bromide on (b)(6) 2013. During follow-up, the oxygen saturation was 90%. The patient does have a history of asthma.

 
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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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3637222
Report Number1644487-2014-00467
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/23/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/20/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2013
Device MODEL Number103
Device LOT Number3125
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/25/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/05/2011
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: 02/20/2014 Patient Sequence Number: 1
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