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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 101 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 101 GENERATOR Back to Search Results
Model Number 101
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/26/2001
Event Type  Injury  
Event Description

It was reported that the patient was referred to have their generator and lead explanted due to lack of efficacy, discomfort and the desire to have an mri (body scan). It was reported that the patient's generator had previously been disabled. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 101
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 Key8381857
Report Number1644487-2019-00385
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 03/01/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/01/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2002
Device MODEL Number101
Device LOT Number2836
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/05/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/26/2001
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: 03/01/2019 Patient Sequence Number: 1
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