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Model Number 103
Event Date 05/23/2013
Event Type  Injury  
Event Description

On (b)(6) 2013 information was received that the physician had had a visit with the patient that morning for follow-up after a recent generator replacement surgery. The physician noted that the patient¿s generator site was exposed by approximately 1 cm, that the generator was visible, but that there appeared to be no signs of infection. The patient¿s mother stated that the patient had been picking at the incision site. The physician stated that the site appeared to be healing and that he would see the patient after another week to monitor the healing process. If the site is not healed by then, the surgeon was considering removing the generator and placing it in another site. The physician did not prescribe any antibiotics during the visit because the site did not appear to be infected. A review of manufacturing records confirmed that both the generator and lead passed all functional tests prior to distribution, as well were properly sterilized prior to distribution. Follow-up with the physician indicated that at the follow-up visit he had observed that the implant, which had been implanted into the axillary incision from prior implant, was visible through the sutures. The physician stated that at the (b)(6) 2013 visit there had been erythema around the generator site and that at the follow-up visit the erythema had decreased considerably so and that the site was beginning to look better and beginning to granulate slowly. The physician stated that if the site does not granulate completely that he would have no choice but to explant the generator and either let the incision heal completely before reimplanting again in that location or placing the generator elsewhere instead. The physician will continue to monitor the situation. Attempts for additional information are still in continuation.

Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead and that they passed all functional tests prior to distribution.

Event Description

On (b)(4) 2013 information was received by the reporter that the patient had been tentatively scheduled for a vns revision surgery on (b)(6) 2013 due to the generator being exposed at the chest incision site. Follow-up determined that the patient instead underwent surgery on (b)(6) 2013. The patient had completely removed the generator from his chest and approximately 5 cm of the lead wire was also exposed. The generator and lead were both explanted by the physician and the physician intends to wait a month to allow the incision sites to fully heal before reimplanting vns in the patient. It was also reported that the patient had a skin condition and will be referred to a dermatologist for diagnosis. The explanted lead and generator have been returned to the manufacturer and will soon undergo product analysis. Attempts for additional information will remain in continuation.

Event Description

Additional information was received stating that the vns patient was re-implanted with a new generator and lead on (b)(6) 2014.

Event Description

A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 3. 072 volts as measured during completion of test parameter 7. 16. 10. 2 (measured diagvbat) of the final electrical test, shows a non-ifi condition. The data in the diagaccumconsumed memory locations revealed that 2. 826% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. Note that a small portion of the lead assembly (body) including the electrode section was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. The additional setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Dried body fluids inside the outer and inner tubing was observed in some areas. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device. Note that since a small 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. No other information has been provided.

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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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key3165711
Report Number1644487-2013-01754
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 05/23/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/12/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2014
Device MODEL Number103
Device LOT Number3353
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/08/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/30/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/19/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 06/12/2013 Patient Sequence Number: 1