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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 High impedance
Event Date 03/22/2017
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

It was reported the patient's vns was programmed off due to high impedance. The patient was scheduled for a full revision. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

The patient underwent a vns generator replacement due to the reported high impedance. The device was tested in pre-op and still showed high impedance. The physician noted the old generator "felt loose" during the explant. When the new generator was implanted on the same lead, the impedance was within normal limits. It was noted the surgeon attempted to re-insert the lead pin into the original generator, but he still received high impedance. The device is not expected to re returned for analysis as the explanting facility is a no return site. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

The date the patient's vns device was evaluated and programmed off was clarified by the physician's nurse. She also stated that the patient's husband had called about it the day before as she was having some painful stimulation.

 
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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 Key6533121
Report Number1644487-2017-03701
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/01/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/30/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/13/2017
Device MODEL Number106
Device LOT Number203655
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/01/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/04/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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