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Device Problem Fracture
Event Date 02/07/2012
Event Type  Malfunction  
Event Description

On (b)(6), 2012 it was discovered that the vns patient also underwent prophylactic generator replacement on (b)(6), 2012. The explanted generator was returned for product analysis on (b)(6), 2012 but the leads were not returned. Product analysis is still underway and has not yet been completed.

Event Description

Additional information was received on (b)(6) 2012, when product analysis was completed on the explanted generator. Bench interrogation/diagnostic test showed that the nearing end-of-service indictor (neos) was set to yes. Results of the bench diagnostic testing indicated the device was operating properly with neos yes. The data in the memory locations revealed that 100. 148% of the battery had been consumed. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications, with the exception of the expected low battery voltage. The battery voltage value stored within the generator, 2. 171 volts, suggests an neos battery partially depleted condition. The electrical test results showed that the pulse generator module performed according to functional specifications. However, the measured 2. 285 battery voltage (generator module post open can) is lower than expected for the percentage of battery consumed value of 100. 148%. Further review revealed that the explanted generator was returned with the output current programmed to 3. 00 ma. The data from the generator shows a high impedance (22183 ohms) estimated occurrence on (b)(6) 2012 (explant (b)(6) 2012) and remained until received into decontamination on (b)(6) 2012 (generator output current programmed to 0. 0ma). The combination of a high impedance value and output current setting required a "vboost" compliance voltage that exceed the maximum compliance voltage capability for the device (>10. 5 v). Longevity estimates are not guaranteed at compliance voltages greater than 10. 5v. In this situation a significant amount of additional current consumption exists, based on the need for a component to remain on (asic remains in a trickle charge state) in order to support the higher electrical load demand. This condition contributes to the disparity between the battery voltage and percent battery capacity that has been consumed, based on the device's internal eos projection system. Other than the noted error, there were no performance or any other type of adverse conditions found with the pulse generator.

Event Description

On (b)(6) 2012 a nurse reported that the vns patient was scheduled for a chest and neck x-ray tomorrow as the neurologist thinks there may be an issue with lead breakage or lead not functioning properly. She stated that a copy of the x-rays would be sent to the manufacturer for review. Attempts for further information have been made but no additional information has been received from the physician. The manufacturer's consultant stated that the epileptologists are not forthcoming with information due to hippa. The patient's implanted product information has been requested from the implanting hospital, but the hospital stated that they would not provide that information without patient consent or attorney request. Since the manufacturer does not have either of these, the product information cannot be obtained. A/p and lateral views of the neck and chest were received and reviewed on (b)(6) 2012. Due to x-ray films provided, it could not be confirmed that the lead pin is fully inserted into the generator connector block. There appeared to be lead behind the generator, so continuity in that portion of the lead could not be fully assessed. No lead discontinuities were seen in the visible portions of the lead. The electrodes could be visualized in the neck, but they appeared to be at an angle to one another. Based on the images provided and given the angle of the electrodes, proper alignment of the electrodes on the nerve could not be confirmed. However, it is noted that there are two previous sets of electrodes present that do not appear to be parallel in relation to the current electrodes. Therefore, the angle of the electrodes may be due to the patient's anatomy, and the electrodes may in fact be placed on the nerve. Based on the x-ray film images provided, no clear cause for the high lead impedance could be found, however it is possible that the lead pin is not fully inserted, there is an unpronounced break in the lead, or a micro-fracture that cannot be seen on the x-ray films provided. In addition, improper alignment of the electrode(s) could not be ruled out as a contributory cause. The patient underwent lead revision surgery on (b)(6) 2012. Attempts for product return will be made.

Manufacturer Narrative

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

Event Description

On (b)(6) 2015 during review of the patient's programming history it was found that the patient has had high impedance since the generator was implanted on (b)(6) 2012. There was programming history through (b)(6) 2012 indicating that the generator was not replaced on (b)(6) 2012 like previously reported. It was also reported that the patient's current generator was implanted on (b)(6) 2012. The patient currently has high impedance; therefore it is unclear if the patient did in fact have a lead replacement on (b)(6) 2012 as planned since there was no confirmation indicating that the lead was replaced. Good faith attempts for further information regarding whether the patient did have a lead revision on (b)(6) 2012 were made but were unsuccessful.

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Type of DeviceLEAD
Manufacturer (Section D)
100 cyberonics blvd
houston TX 77058
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 Key2638515
Report Number1644487-2012-01679
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 06/11/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/03/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/20/2015
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