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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Device Problem Insufficient Information
Event Date 12/11/2015
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that the patient developed a post-surgical infection. The infection presented as red streaking down the patient's left arm, and she was treated with antibiotics. The symptoms of infection had reportedly resolved at that time. Subsequently, the patient visited the emergency room with the red streaking returning and accompanied by pain and swelling in the left arm. The physician ruled out deep-vein thrombosis, and concluded with a diagnosis of post-operative thrombophlebitis. No interventions for the thrombophlebitis have occurred. The patient was not admitted to the hospital. The notes received from the physician appear to indicate that the patient has her generator implanted in the left arm. A review of device history records showed that the generator was sterilized prior to distribution. No additional relevant information has been received to date.

 
Event Description

Follow up communication indicated that the patient's generator was actually implanted in her left armpit. Additionally, it was indicated that the patient was a regular smoker. This was the same location that her previous generator was located. No additional pertinent information has been received to date.

 
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Brand NamePULSE GEN MODEL 106
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
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 Key5397383
Report Number1644487-2016-00143
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Followup
Report Date 01/04/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/28/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/22/2017
Device MODEL Number106
Device LOT Number203585
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/29/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/02/2015
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: 01/28/2016 Patient Sequence Number: 1
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