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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Device Problem High impedance
Event Date 10/09/2018
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported that the patient's device showed high impedance and the patient started experiencing pain. As a result the patient's device was turned off, and the patient was then referred for a x-rays to determine if there was a lead fracture. X-rays were reviewed by the physician however the cause of the high impedance was not determined. Therefore, the patient was then referred for surgery. During the surgery, it was found that when the lead was unscrewed, wiped down, and securely re-inserted, the impedance tested as ok. The case was completed and the impedance returned to normal. 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 - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8055167
Report Number1644487-2018-02001
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 11/09/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/09/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number106
Device LOT Number204419
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/16/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/20/2018
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: 11/09/2018 Patient Sequence Number: 1
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