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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/26/2017
Event Type  Injury  
Manufacturer Narrative

 
Event Description

The surgeon reported that the patient was having pain at the implant site. The surgeon stated that everything looked good and that the generator was sitting well in the pocket, and that the wires seem to be intact and correctly located. The patient felt the pain at the electrode site during stimulation and described it as a shocking sensation during magnet stimulation. The doctor believed the patient was doing well and there were no issues with the generator or lead. Diagnostics were within normal limits and the settings were felt not to be contributory to the patient's pain, but the patient was complaining of pain at the generator site. The patient has been referred for surgery. No known surgical intervention has occurred to date. No other relevant information has been received to date.

 
Event Description

Surgery has been completed for this patient's generator replacement. The product has not been received by the manufacturer to date. No other relevant information has been received to date.

 
Event Description

Additional information was received that the explanted product is held for 2 years and 3 months by risk management at the explant facility before the product will be returned to the manufacturer. The product has not been received by the manufacturer to date. No other relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 106
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key7154501
Report Number1644487-2017-05088
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 02/19/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/29/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/18/2019
Device MODEL Number106
Device LOT Number204008
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/16/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/06/2017
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: 12/29/2017 Patient Sequence Number: 1
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