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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 10/01/2018
Event Type  Injury  
Event Description

It was reported that the patient was referred for vns explantation surgery due to irritation along the chest and left axilla, which the patient attributed to the vns. The vns was previously disabled for reasons unrelated to the vns. No relevant surgery is known to have occurred to date. No additional relevant information has been received to date.

 
Event Description

Follow up with the physician's office revealed that the physician was unable to provide an assessment on the relation of the pain to the vns as the patient also has torticollis, indicating that the physician believes that the condition could also be a possible cause. It was stated that the surgical intervention was for the patient's comfort. No diagnostics were available as the vns was not programmed on.

 
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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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8091038
Report Number1644487-2018-02110
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 12/14/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/20/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/18/2007
Device MODEL Number102
Device LOT Number014714
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received12/05/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/19/2005
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: 11/20/2018 Patient Sequence Number: 1
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