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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 Adverse Event Without Identified Device or Use Problem
Event Date 10/10/2018
Event Type  Injury  
Manufacturer Narrative

"device evaluated by manufacturer": device evaluation is not necessary as the reported events are not related to device functionality.

 
Event Description

The physician's assistant (pa) reported that the patient presented with left neck pain so pain injections were attempted, which did not resolve the issue. The patient was then sent for x-rays. Per the x-rays the pa believes the generator migrated due to potential chest compressions at an er visit and the er visit was unrelated to vns. It is not "know" when the patient was in the er. The pa believed the migration caused the neck pain due to the lead tightening. The patient was referred for surgery to suture the generator higher. The pa stated the diagnostics were normal. X-ray images were assessed by the manufacturer as well. Based on the images provided, the generator was placed normally in the left chest. Due to the poor quality of the image, nothing further could be assessed concerning the generator. The lead was observed in the patient¿s neck and appeared to be routed toward the patient¿s left chest. Due to the poor quality of the image, nothing further could be assessed concerning the lead. Based on the images provided, there is no obvious cause for the reported pain and generator migration. Additional information from the pa reported that the surgery will be for patient comfort and to preclude serious injury. The settings were initially turned off after the pain to see if there would be a reduction in pain, which there was not. The settings were later turned back on to lower settings. The physician later decided to replace the generator because it was already 2 years old instead of just performing a revision. No additional 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 Key8034826
Report Number1644487-2018-01950
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 11/02/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/02/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/10/2018
Device MODEL Number106
Device LOT Number5067
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/10/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured10/26/2016
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: 11/02/2018 Patient Sequence Number: 1
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