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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/12/2016
Event Type  Injury  
Event Description

It was reported by the patient's mother that the patient was experiencing painful stimulation when using the vns magnet. It was stated they had communicated the pain to the physician and the physician decreased the vns settings as they believed this would resolve the pain; however, the pain continued. It was noted the patient has fallen a few times, but the mother was unaware of any other trauma which could have caused the pain. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

The event of painful magnet mode stimulation did not lead to a death or serious injury, nor would it be expected to lead to a death or serious injury if it were to recur. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

It was later noted the patient was referred for a revision and that there was a possible lead pin insertion issue. No known surgical interventions have occurred to date.

 
Event Description

An implant card was later received showing the patient had undergone a full revision surgery. The vns generator replacement was prophylactic and the lead replacement was because the "leads were uncoiled due to tension. " attempts for additional relevant information have been unsuccessful to date. The explanted lead and generator are not expected to be returned to the manufacturer for analysis.

 
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Brand NamePULSE GEN MODEL 105
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 Key6230577
Report Number1644487-2017-02994
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial,Followup,Followup,Followup
Report Date 03/28/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/06/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2016
Device MODEL Number105
Device LOT Number3888
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Device Age2 yr
Event Location Other
Date Manufacturer Received03/10/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/21/2014
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: 01/06/2017 Patient Sequence Number: 1
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