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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/18/2018
Event Type  Injury  
Manufacturer Narrative

Device evaluated by mfr? - device evaluation is not necessary as the reported events are not related to the functionality or delivery of therapy of the device.

 
Event Description

It was reported by the patient that they experienced an allergic reaction following vns surgery and went to the emergency room. The patient indicated that they experienced severe swelling at the chest and neck site as well as difficulty breathing related to their allergic reaction. The physician indicated that the patient had a rash around the surgical sites related to the patient being allergic to the agent used to prepare the surgical site prior to surgery, chlorhexidine prep. The physician indicated that the patient was also allergic to the doxycycline antibiotics consumed. A review of the device history records showed that both the lead and generator were sterilized prior to distribution. No further relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 106
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8251305
Report Number1644487-2019-00085
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 01/15/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/15/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number106
Device LOT Number204466
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received12/23/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/03/2018
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: 01/15/2019 Patient Sequence Number: 1
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