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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 102 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/08/2005
Event Type  Injury  
Manufacturer Narrative

 
Event Description

Clinic notes indicated that the patient experienced bradycardia with high vns stimulation on their current m105 generator (captured in mfr. Report # 1644487-2014-02030). It was also implied that it may have occurred with their initial generator (as captured in the current report). No further relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 102
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 Key8341579
Report Number1644487-2019-00317
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 02/14/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/14/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/05/2006
Device MODEL Number102
Device LOT Number011608
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/23/2014
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/21/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/09/2004
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: 02/14/2019 Patient Sequence Number: 1
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