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Model Number 300-20
Event Date 04/21/2011
Event Type  Malfunction  
Event Description

It was reported to the manufacture from a explanting physician in (b)(6) that he had a pt with lack of efficacy with their vns therapy and who was having pain at their generator site, left infraclavicular area. It was reported that in the last 2 yrs, the pt had experienced pain in the area of the generator in the left infraclavicular and axillary regions. The generator had been turned off for 3 yrs due to battery exhaustion. The pt insisted on having their vns system explanted related to their pain events. During the explant procedure at a depth of about 1. 5 cm, the first securing clip was found. The suture was detached and the clip dissected from the fibrin sheath. The cable was followed in the proximal direction and the next securing clip found after 1 cm at the level of the carotid. Here, the suture of the securing clip had pierced the adventitia of the carotid artery. The fibrin sheath surrounded the securing clip, forming a cuff on the carotid. Since the stimulator cable ran through a scar between the jugular and carotid arteries into the depths, dissection was attempted her as well. The project had to be aborted, however, because it was too risky, and both the carotid and the jugular could have been injured. Therefore the entire lead body was not explanted. Their explanted generator was returned for analysis. In the product analysis laboratory it was determined that the device was at and end of service condition; an open can measurement of the battery voltage confirmed that the battery was depleted. Based on the bench analysis and the electrical test results, the device exhibited current consumption rates that were within specification; thereby, demonstrating normal battery depletion to an end of service condition. No programming history records were found; consequently, a battery life calculation could not be performed. The device performed according to functional specifications. Therefore, the electrical performance of the generator, as measured in the product analysis laboratory, will be used to conclude that no performance or any other type of adverse condition was found with the generator. Addressed in medwatch report number: 1644487-2011-01362. A portion of the pt's explanted lead was returned for analysis. There was a confirmed lead discontinuity. Note that a portion of the lead assembly (body), including the electrodes was not returned for analysis; therefore a complete eval could not be performed on the entire lead product. During the visual analysis of the returned 258mm portion the end of the marked connector quadfilar coil appeared to be broken approx 154mm from the connector bifurcation. Visual analysis was performed and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. It is unk if the breaks occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. The abraded openings found on the outer and inner silicon tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. No other obvious anomalies were noted. The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pins at one point in time. Continuity checks of the returned lead portions were performed, during the visual analysis, with no other discontinuities identified. Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portions of the device which may have contributed to their reported pain. Note that since a portion of the lead assembly (body) including the electrode array section was not returned for analysis, and eval and resulting commentary cannot be made on that portion of the lead.

Manufacturer Narrative

Device malfunction occurred, but did not cause or contribute to a death.

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Manufacturer (Section D)
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
MDR Report Key2194878
Report Number1644487-2011-01576
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/15/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/13/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2006
Device MODEL Number300-20
Device LOT Number010388
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer05/18/2011
Is The Reporter A Health Professional? Yes
Date Manufacturer Received06/15/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/01/2004
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial