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Model Number ASKU
Event Date 11/14/2012
Event Type  Malfunction  
Event Description

Additional information was received from the nurse practitioner at the neurologist's office reporting the patient did come in for clinic visits and diagnostics were done on her vns which is typical. She was exhibiting behavior that they thought were seizure related. The seizure activity is not believed to be above pre-vns baseline levels but no additional information was provided regarding the seizures. Diagnostics revealed high impedance on (b)(6) 2012, and chest/neck x-ray was performed on this date which found a fractured wire. The device was subsequently turned off on (b)(6) 2012. Lead was replaced in another town so the additional follow-up was performed by another physician's office. Attempts for additional information from the currently treating/local nurse practitioner have been unsuccessful to date.

Manufacturer Narrative

Date of event, corrected data: the initial report inadvertently reported the date incorrectly due to new information received.

Event Description

It was initially reported that the patient had vns replacement on (b)(6) 2012 placed on the right side. Follow-up with the implanting surgeon was performed which revealed that the lead was replaced on (b)(6) 2012. (the generator was not replaced as it was recently implanted on (b)(6) 2012. ) the lead was implanted on the right vagus nerve rather than the left vagus nerve, which is off-label. Manufacturer labeling indicates the lead to be implanted on the left vagus nerve. The lead was implanted on the right vagus nerve due to 'high risk for nerve injury with a third neck dissection, particularly given the prior injury' of vocal cord paralysis. The vocal cord paralysis is reported in mfg report number: 1644487-2004-00262. The lead was replaced due to high lead impedance first observed in (b)(6) 2012, and x-ray images performed on (b)(6) 2012 reportedly showed a fracture of one of the lead wires. There was no patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. A copy of the x-rays will not be provided to the manufacturer without patient signed release. The generator was turned off prior to surgery sometime in (b)(6) 2012. The patient exhibited atonic seizures with the high impedance, but it is unclear if there was an increase in frequency or change in seizure pattern. Attempts for additional information from the treating nurse practitioner at the physician's office who found the high lead impedance have been unsuccessful to date. Additionally, attempts to medical records for lead product information have been unsuccessful to date. Attempts for product return have been unsuccessful thus far.

Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death or serious injury.

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Type of DeviceLEAD
Manufacturer (Section D)
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key2933487
Report Number1644487-2013-00226
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/03/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/29/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberASKU
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/29/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 01/29/2013 Patient Sequence Number: 1