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Model Number 103
Event Date 01/06/2012
Event Type  Injury  
Event Description

Additional information was received on january 26, 2012 when the explanted lead and generator were returned to the manufacturer for product analysis. The electrode array portion of the lead was not returned for analysis, and therefore, an evaluation and resulting commentary cannot be made on that portion of the lead. Visual examination of the lead identified what appears to be a cut opening and a puncture in the outer silicone tubing. No obvious damage to the inner silicone tubing of the lead coils was noted at these locations. The conditions are consistent with those observed due to the explant process. The lead assembly has remnants of what appear to be body fluids inside the inner silicone tubing of the lead coils. The assessment of the believed leakage path was the cuts or punctures made in the lead during the explant procedure. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Product analysis on the generator was completed on february 9, 2012. Electrical test results demonstrate that the pulse generator performs according to functional specifications and there are no adverse functional, mechanical, or visual issues identified with the returned generator.

Event Description

On (b)(6) 2012 the vns patient reported that since (b)(6) 2011 she has been experiencing pain in her head that is different from a headache, as well as pain in her right arm and an increase in seizures. The patient stated that the pain usually occurs after she has had a seizure. The patient did not know the relation of her increase in seizures to pre-vns baseline levels. The patient reported to the case manager that she is not currently seeing a neurologist as she has a different insurance now. The patient sated that she is feeling a constant low voltage electrical shock in her brain. The patient taped her magnet over the device and said she experienced a burning feeling from the magnet. She said there was a burn mark on her skin when she removed the magnet. She stated that when the magnet was taped over the device, she did not feel the painful stimulation. The manufacturer's consultant reported that the patient had previously lied about her insurance so finding a neurologist was difficult. They found one the patient could see but the patient's husband refused to drive her there. The patient then showed up at the emergency room where the patient's real insurance information was discovered. The patient was seen by a neurologist and he disabled her device because of her reported pain. He went ahead and referred her to a surgeon because of the pain but she screamed at the neurologist and the staff so he asked her to leave and he will not see her again. The patient stated that she still felt painful stimulation even when the device was off and that the magnet stimulation burned her when she swiped the magnet. The clinic notes from the patient's visit from the neurologist on (b)(6) 2012 were obtained which stated that the patient was tearful and hysterical over the pain due to vns. The patient was angry that vns has not helped her. The pain and burning was reported to have started on (b)(6) 2012. The patient stated that she is currently taking hydrocodone for the pain but asked for more pain medication. The neurologist tried to run diagnostics but the patient would not tolerate it and remained hysterical and belligerent. The vns generator site was evaluated and the neurologist saw no bruising or burn marks that the patient claimed to have. The manufacturer's consultant reported that the patient had her generator and lead explanted on (b)(6) 2012 due to a device malfunction. The patient's husband did not want the explanted product sent to the manufacturer for product analysis; however the surgeon did want the devices sent to the manufacturer. The husband became verbally abusive and was provided the options of having the manufacturer perform product analysis on the device or have the device sent to him without product analysis if he signed a release form.

Event Description

On (b)(6), 2012 additional information was received when the patient further stated that while she was still implanted, she visited the emergency room twice because of burn marks received when using her magnet. The patient stated that both emergency room physicians advised her that she needed the device explanted before she died from it. However clinic notes from the patient's visit from the neurologist on (b)(6), 2012 were obtained which stated the vns generator site was evaluated and the neurologist saw no bruising or burn marks that the patient claimed to have. The patient said she can't wear her hair down because when it touches her neck she has severe pain. The patient additionally stated that she had traumatic brain injury (tbi) before being implanted and therefore should not have been implanted in the first place.

Manufacturer Narrative

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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
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key2434478
Report Number1644487-2012-00241
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/06/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/01/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2011
Device MODEL Number103
Device LOT Number2572
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/26/2012
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received02/07/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/22/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 02/01/2012 Patient Sequence Number: 1