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Model Number 102R
Event Date 11/16/2012
Event Type  Injury  
Event Description

Additional information was received from the patient's treating physician. The patient event was classified as bradycardia with asystole. Patient experienced bradycardia and asystole; heart rate prior to event: 72/min,heart rate during event: 35/min. Event not occur intra-operative. Arrhythmia event date (b)(6) 2012 and repeatedly during a period of approx. 1 month before symptoms suggesting arrhythmia: vertigo(presyncopal). No traumatic events prior to arrhythmia, and no triggers the patient is taking medication:valproate 6000 - 150 - 900mg, levetiracetam 2000 - 1000 - 1000mg, lacosamide 200 - 0 - 150mg. Event did not follow a change in medication. Arrhythmia does not correlate with on time. Event did not occur during device diagnostics (not performed), or change in settings. Diagnostic studies to diagnose arrhythmia: ecg. The patient's treating physician believes the event is related to vns. The event does not occur without the stimulation being present. Their device was disabled. The patient wast hospitalized and in intensive care and cardiology department when this event occurred. Since their device has been disabled their arrhythmia has not re-occurred. Four x-ray images (2 chest ap, 1 neck ap, 1 neck lateral) were received for review. The generator was visualized in the left upper chest, the front of the generator is facing forward. The filter feed-through wires appear to be intact and the lead connector pins are fully inserted into the generator connector block. Only a limited section of the lead is visible and could be assessed, as some is located behind the generator. The electrodes, strain relief bend and loop are outside the view, therefore it cannot be ascertained if these are present or if the electrodes are correctly aligned on the vagus nerve. No anomalies were noted.

Event Description

It is unknown if the device will be programmed on again.

Event Description

A vns treating physician in (b)(6) reported to our country manager that they had a patient who was approximately (b)(6), female with epilepsy. It was reported that the patient had fallen recently and landed on back/head. The patient was now having cardiac rhythm disturbances, connected to vns stimulation on time period. Their cardiologist has done check and sees connection. The issue started two months ago. X-rays will be planned/ordered, possibly electrographic analysis to see if lead ok. Generator turned off. Device has been disabled for fear that a further cardiac risks could develop. The patient's heartbeat of patient now slower, with vns on period. Checks done by cardiologist: no cardiac disease. Output current 2 ma, frequency 30 hz, pulse width 500 s, duration 30 s, interval 5 min. Investigation is underway. At this time no further information has been attained.

Event Description

Reporter indicated the patient had the vns generator and lead explanted on (b)(6) 2013 and no new devices were implanted. The explanted devices were returned to the manufacturer on (b)(6) 2013, with paperwork indicating the devices were explanted due to "cardiac arrhythmia". Product analysis of the generator and lead is pending.

Event Description

Product analysis of the vns generator and lead was completed. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. The abraded openings and slice and incision marks found on the lead outer silicone tubing most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. The abraded openings found on the inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the inner silicone tubes. Abraded openings were observed on the outer and inner silicone tubes. With the exception of abraded openings, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, only abraded openings were observed. Note that since a portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Additional follow up with the physician revealed that additional vns programming history for the patient was not available, and that the patient did have trauma in the past, but the trauma was not specified.

Manufacturer Narrative

Product serial number: corrected data updated to correct serial number. Manufacturer reviewed x-rays of implanted device. X-rays reviewed of implanted device and no anomalies noted.

Manufacturer Narrative

Device failure is possible in the lead portion not returned.

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Type of DevicePULSE GEN MODEL 102R
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 Key2870936
Report Number1644487-2012-03317
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/19/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/12/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2009
Device MODEL Number102R
Device LOT Number200690
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/03/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/24/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/08/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 12/12/2012 Patient Sequence Number: 1