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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL UNKNOWN GENERATOR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury  
Event Description

It was reported via clinic notes that a patient had an abdominal infection with a past generator replacement surgery. It is unknown which of the patient's surgeries the infection occurred after. The surgeon reported that the abdominal infection was unrelated to the vns implant site. The patient remained in the hospital after surgery for the infection to be treated. No additional relevant information has been provided to date.

 
Event Description

It was reported that the physician did not know more about the abdominal infection mentioned in the clinic notes as she did not have a prior history with the patient. The patient reportedly had a previous gallbladder surgery at another surgical facility, but the date and outcomes of the surgery were unknown to the physician. The physician did not state whether the gallbladder surgery was or was not related to the abdominal infection. No additional information has been provided.

 
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Brand NamePULSE GEN MODEL UNKNOWN
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 Key6415443
Report Number1644487-2017-03425
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/14/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/17/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/22/2017
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: 03/17/2017 Patient Sequence Number: 1
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