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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 302

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CYBERONICS - HOUSTON LEAD MODEL 302 Back to Search Results
Model Number 302-20
Device Problem High impedance
Event Date 01/09/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that the patient was seen again after a lead pin reinsertion surgery, and high impedance was observed. Diagnostics further noted that the output current was not delivering and the patient was complaining of a shocking sensation to her neck. The patient was sent for x-rays and was to be referred for possible lead revision surgery. Clinic notes from the office visit were received and reviewed. It was stated that since the patient's last visit, the patient was experiencing an intermittent "shocking" sensation at the left side of the neck, coughing more, and had chocked while eating three times, one of which became cyanotic and required a heimlich maneuver. The noted diagnostics confirmed the high impedance and low output current delivered that was reported. It was stated that x-rays of the chest and neck showed no apparent lead break. Settings were decreased for the adverse event of painful stimulation, coughing, and choking. Ap and lateral chest and neck x-rays were received for review. The generator placement appeared to be normal in the left axillary chest area. Due to the quality and angle of the images provided, complete lead pin insertion and feed-through wire integrity could not be assessed. The lead was observed in the patient¿s neck appeared to be routed toward the patient¿s left chest. Due to the quality and angle of the image, strain relief and integrity of the lead could not be assessed. A portion of the lead is routed behind the generator. Based on the images provided, no obvious cause of the adverse events or high impedance was identified. Note that the presence of a gross fracture in the portion of the lead excluded from the images or a micro-fracture along the lead body cannot be ruled out. Revision surgery occurred and it was noted that the explanted product was not expected to be returned for analysis as the hospital discards products after surgery. It was specified that only the lead was revised, with the replacement lead placed on the left vagal nerve. Pin reinsertion was not tested. No device was received to date. No additional relevant information was received to date.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
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
rachel kohn
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8300514
Report Number1644487-2019-00214
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 02/03/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/03/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/15/2006
Device MODEL Number302-20
Device LOT Number11652
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/09/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/21/2004
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: 02/03/2019 Patient Sequence Number: 1
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