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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 304

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CYBERONICS - HOUSTON LEAD MODEL 304 Back to Search Results
Model Number 304-20
Device Problem High impedance
Event Date 09/14/2018
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

It was reported that high impedance was seen from an implant surgery. Three diagnostic tests were performed in the open chest pocket, showing impedance within normal limits. The surgery was completed with no issues and the patient was closed. Following the surgery, the device was turned on to minimal settings. About 6 hours post-operation, the neurologist found that impedance was high. The same high impedance reading was confirmed with a second programmer and the device was turned off. The following day, impedances were found to be within normal limits and the device was turned back on. The patient tolerated the stimulation well and subsequent impedances were within normal limits. The patient was titrated up and was doing well. It was noted through follow up that the patient was small and had a small nerve. There was no unusual swelling or hematoma noted during surgery. Device history records were reviewed for the implanted generator and lead. Both devices were confirmed to have passed all quality inspections prior to distribution. Programming data was reviewed and confirmed that impedance appeared to have increased from within normal limits to high impedance back to normal impedances within 24 hours. No other anomalies were noted. It was later updated that the patient was admitted to the emergency room because he was not able to speak. It was noted that the patient was well in the morning and was dropped off at school talking normally. The school had later called stating that the patient had no verbal communication. There was no sign of pain or discomfort. The parents taped the magnet over the generator and headed to the emergency room. It was stated that after approximately 30 minutes of having the magnet taped over, the patient's speech returned and was described as "raspy". The device was interrogated and found no issues. An ekg was ordered and noted to be unremarkable. The device was turned off. The patient was doing well. Programming data from the event was received and reviewed. No anomalies were noted from the device. No additional relevant information has been received to date.

 
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Brand NameLEAD MODEL 304
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key7950501
Report Number1644487-2018-01801
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 10/10/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/10/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number304-20
Device LOT Number204567
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/14/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/31/2018
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: 10/10/2018 Patient Sequence Number: 1
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