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Model Number 102
Event Date 04/23/2013
Event Type  Injury  
Event Description

On (b)(4) 2013 it was reported that the vns patient has been experiencing a shocking sensation in her neck when she turns her head a certain way since (b)(6) 2013. No causal or contributory programming or medication changed preceded the onset of the event and no patient manipulation or trauma occurred. The physician stated the normal and system diagnostic results were ¿abnormal¿. The physician also stated that there has been no settings change since (b)(6) 2009. The patient¿s vns was turned off due to the shocking sensation. The physician mentions that the cause of the shocking sensation was a ¿faulty cable, stressed from excessive movement of the battery after the patient¿s recent weight loss¿. The patient described her generator as flipping inside her chest at night that started prior to (b)(6) 2013 and stated that she has lost 80 lbs since her vns implant. It was mentioned that the patient¿s generator is going to be replaced as an intervention. The physician stated that no direct patient manipulation or trauma occurred that is believed to have caused/contributed to the device flipping but that the patient had undergone bariatric surgery, resulting in substantial weight loss, and thereby resulting in the battery pack becoming loose and highly mobile underneath the skin. The physician again mentioned that ¿this subsequently stressed the cable¿. The patient also mentions that starting (b)(6) 2013 the patient felt her device was constantly stimulating and not cycling off even when she held the magnet over the device. The physician stated that the patient¿s magnet was not secured correctly over the device when the patient came into the office. The physician was able to disable the patient¿s device in the office and device diagnostics performed on (b)(6) 2013 were within normal limits. The patient was noted to have a mild cough/clearing of throat approximately every 5-10 seconds that occurred due to stimulation. Although surgery is likely, it has not occurred to date.

Event Description

It was reported that the patient underwent surgery at which time the generator was confirmed to be programmed off and not at end of service. A new generator was placed and it was reported that the existing lead check out "ok" and was not replaced. It was reported that the new generator was programmed on and is "functioning". The implant card confirmed that the patient underwent generator replacement. The lead impedance was not marked. The generator has not been received by manufacturer for analysis.

Event Description

The physician provided the operation notes from the (b)(6) 2006 vns implant to provide information on the sutures used. The notes state: "the lead was connected to the battery device. Lead tests were then performed showing the lead to be adequate both externally and after the device had been implanted subcutaneously. Both incisions were then approximated using vicryl for the subcutaneous tissues and staples for the skin. ".

Manufacturer Narrative

Incorrect date of birth was inadvertantly listed on the initial mdr.

Manufacturer Narrative

Brand name / type of device / name / model # / serial # / lot# / expiration date / device manufacture date; corrected data: the information provided in supplemental manufacturer report #03 indicated that the suspect device was the generator; however, the suspect device was inadvertently not updated in the report.

Event Description

Additional information was received stating that the generator was near end of service. The explanted generator was returned to the manufacturer for analysis. The as-received generator was not at end of service but the elective replacement indicator (eri) was set. The as-received output current was programmed to 0ma so it wouldn't be expected that the battery voltage continued to deplete after surgery. The generator septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. Monitoring of the device output signal showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. The pulse generator module performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.

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Type of DeviceGENERATOR
Manufacturer (Section D)
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key3199770
Report Number1644487-2013-01999
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/11/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/01/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2007
Device MODEL Number102
Device LOT Number013118
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/18/2014
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received03/14/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/16/2005
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 07/01/2013 Patient Sequence Number: 1