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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 1000 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 1000 GENERATOR Back to Search Results
Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/04/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

Initial report was that a patient was admitted into a hospital due to tachycardia. The patient recently started to experience bradycardia that occurred with low blood pressure. The physician did not know if the events were occurring with device stimulation. Further information was received that the patient had been admitted to the hospital due to the infection. No other relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 1000
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 Key8649294
Report Number1644487-2019-01030
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 05/29/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/29/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number1000
Device LOT Number204553
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received05/04/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/20/2018
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: 05/29/2019 Patient Sequence Number: 1
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