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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 01/01/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that the patient underwent surgery to explant his lead and generator. The neurologist indicated that the reason for explant was lack of efficacy, the patient said that the vns was uncomfortable and because the patient was unable to tolerate increases in output current. The suspect product was received for product analysis. The generator's device output signal was monitored for 24 hours under a simulated body temperature environment. The device delivered the expected stimulation consistently. No anomalies were found. No further relevant information has been received to date.

 
Manufacturer Narrative

 
Event Description

Product analysis was completed on the explanted lead. The majority of the lead body and the electrode array were not returned. Continuity checks were performed and no discontinuities were found. No other obvious anomalies were found. No further relevant information has been received to date.

 
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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 Key6396741
Report Number1644487-2017-03341
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/04/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/10/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/14/2015
Device MODEL Number105
Device LOT Number202614
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/07/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/10/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/14/2013
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: 03/10/2017 Patient Sequence Number: 1
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