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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL UNK GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL UNK GENERATOR Back to Search Results
Event Date 09/19/2014
Event Type  Injury  
Event Description

It was reported that the neurologist noted redness at the generator site and thought the surgeon should order antibiotics. The patient denied pain or drainage but indicated that the generator site was warm. The patient later reported that she was seen by her primary care physician for an upper respiratory infection and that the antibiotics she was given for that also decreased the redness to the generator site. The patient has been applying neosporin to the incision sites and the chest incision is now light pink and no longer feels warm.

 
Event Description

Additional information was received stating that the patient went to the er on (b)(6) 2014 due to chest pain associated with stimulation. The er physician was advised to use the magnet to temporarily disable the device. Further follow up with the physician's office indicated that the patient had recovered from infection on (b)(6) 2014.

 
Manufacturer Narrative

 
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Brand NamePULSE GEN MODEL UNK
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 Key4262265
Report Number1644487-2014-03078
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 10/20/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/19/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received11/24/2014
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: 11/19/2014 Patient Sequence Number: 1
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