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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Event Date 01/01/2016
Event Type  Injury  
Manufacturer Narrative

 
Event Description

Notes dated (b)(6) 2016 state that the patient's battery is reported to be near end of service and requires replacement. Notes dated (b)(6) 2016 state that one week prior the patient had onset of shooting pain in her left axilla. The notes state that the patient was seen urgently by the neurosurgeon upon complaints of pain/discomfort of concern for vns malfunctioning. Noted to have protruding piece of chest wall tissue of concern for a surgical clip vs wire/generator attachment. Vns was interrogated and found to have normal impedance. Chest wall protrusion of concern for adhesions that may be contributing to muscular skeletal discomfort. The vns was turned off for 20-30 minutes and then turned back on, patient was observed during this time for side effects/adverse effects and no discomfort was noted. It was indicated that on (b)(6) 2016 the patient had surgery. The generator was not changed but it was indicated that something was done to the leads although it is not clear at this time what they did. Post-op impedance was still within normal limits.

 
Manufacturer Narrative

Information received the day the initial mdr was submitted was inadvertently omitted from the initial mdr.

 
Event Description

The patient was set to have surgery but it was determined that no replacement of the generator was necessary. The leads were manipulated and it was stated that the device seems to be ok. Clarification from the nurse was obtained which showed that the reason for the planned replacement was solely for the patient's neck pain. There was no chest pain, only pain in the neck area of the vns. She confirmed the battery was still good and impedance levels were fine. The surgeon also took some x-rays and determined the positioning of the tie-down (or what they called the elastic flange) was likely causing her discomfort against the skin. She stated that they dissected the flange out and because there was enough scarring around the lead they did not need to secure it again. The procedure was for patient comfort.

 
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Brand NameLEAD MODEL 304
Type of DeviceLEAD
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 Key5435350
Report Number1644487-2016-00299
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Followup
Report Date 01/19/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/12/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2017
Device MODEL Number304-20
Device LOT Number202668
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/15/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/09/2013
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: 02/12/2016 Patient Sequence Number: 1
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