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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL UNK GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL UNK GENERATOR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury  
Manufacturer Narrative

(b)(4). Device evaluation is not necessary as the infection is not related to the functionality or delivery of therapy of the device.

 
Event Description

The patient reported that she became infected after a replacement surgery in 2015, which led to the need to have device explanted and re-implanted in 2015. The surgeon from the patient¿s first two replacement procedures could not confirm whether or not patient presented with infection for surgery, since the surgeon has moved offices and discarded the patient's records. Additionally, the implanting physician did not have the resources to pull the patient's records from storage; and therefore, the office would not confirm if the patient had presented infection due to this surgery. No other relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL UNK
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
rachel kohn
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8483842
Report Number1644487-2019-00643
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 04/04/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/04/2019
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 Answer Provided
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/13/2019
Was Device Evaluated By Manufacturer? No
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: 04/04/2019 Patient Sequence Number: 1
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