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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 08/03/2015
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

High impedance was found at a patient铠first vns dosing appointment after initial implant. The device was not turned on and the patient has not experienced any discomfort. X-rays of the implanted device were reviewed by the manufacturer. The connector pin did not appear fully inserted into the connector block. The lead wires appeared intact at the connector pin.

 
Manufacturer Narrative

Event description, corrected data: the report of the patient's consult for surgery was inadvertently not included on the initial report.

 
Event Description

The patient has had a surgical consult scheduled for revision of the lead pin. No known surgery has occurred to-date.

 
Event Description

Lead pin insertion revision surgery was performed (b)(6) 2015. The lead pin was removed and then re-inserted and the impedance issues were reported to be corrected.

 
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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 Key5039651
Report Number1644487-2015-05627
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Followup,Followup
Report Date 08/03/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/28/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/02/2017
Device MODEL Number106
Device LOT Number4405
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/06/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/10/2015
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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