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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-30
Event Date 09/01/2013
Event Type  Injury  
Event Description

It was reported that the patient went to the surgeon after being referred from her psychiatrist. The surgeon reported that he was unsure what the problem was and has no plans to follow-up with the patient. The patient reported that about a month ago she though her device stopped working because she felt like it wasn't working for her depression. The patient reported that her depression was not worse than it was pre-vns baseline. The patient reported that she saw her physician and the device was programmed off because she felt achy all over and her physician thought there may be an issue (short) with the lead. The patient was unsure if diagnostics had been performed at that time. The patient stated that the device will remain off for now and that she will only proceed with surgery if her insurance will pay for it because it is expensive.

 
Manufacturer Narrative

 
Event Description

Additional information was received from the physician's office. The patient has a device that is misfiring, low battery, or completely out. This was detected in (b)(6) 2013. The device was disabled due to the feelings it was giving the patient. No other information was provided.

 
Manufacturer Narrative

Manufacturer reviewed device history records. Review of the generator and lead device history records confirmed all quality tests were passed prior to distribution.

 
Event Description

It was reported the patient's device was programmed off in (b)(6) 2013.

 
Manufacturer Narrative

Describe event or problem, corrected data: the supplemental report #2 inadvertently did not include this information.

 
Event Description

Review of the manufacturer¿s in-house programming history revealed that on (b)(6) 2013 high impedance had been found on systems diagnostics. Additional relevant information has not been received to-date. No known surgery has occurred to-date.

 
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Brand NameLEAD MODEL 302
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 Key3441194
Report Number1644487-2013-03350
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative,COMPANY REPRESENTATI
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/22/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/31/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2010
Device MODEL Number302-30
Device LOT Number200451
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received04/27/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/13/2007
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: 10/31/2013 Patient Sequence Number: 1
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