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Model Number 103
Event Date 11/25/2012
Event Type  Injury  
Event Description

During a return product call from a hospital personnel, it was reported that the patient had generator explant on (b)(6) 2012 due to infection. It was reported by the hospital facility that the lead was not explanted. The generator and lead were later received by the manufacturer for product analysis on (b)(4) 2012. However, product analysis has not been completed to date. Attempts for additional information from the surgeon have been unsuccessful to date. Notes from the manufacturer representative present at vns implant surgery revealed that there were no complications during procedure. Systems diagnostics completed without difficulty.

Event Description

An implant card was later received on (b)(6) 2013 reporting that the patient was re-implanted with vns on (b)(6) 2013 after previously being explanted due to infection. The company representative reported that there were "no issues" during implant.

Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description

Return product form indicated that both the generator and lead were explanted on (b)(6) 2012 due to "patient infection at site. " replacement was not indicated. The surgeon reported on (b)(6) 2012 that the infection and related symptoms (wound dehiscence with pus) were first observed on (b)(6) 2012. The infection was at the generator site, and the surgeon indicated the infection was believed to be related to the presence of the device. The patient may be re-implanted in the future. No patient manipulation or trauma occurred that is believed to have caused/contributed to the infection. Cultures were taken to confirm the infection, so antibiotics were administered. The results indicated "no growth. " product analysis of the generator and lead was completed. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. An analysis was performed on the returned lead portion. Note that the lead assembly (body) including the electrodes 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. The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pin at one point in time. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. There is no evidence to suggest an anomaly with the returned portion of the device.

Manufacturer Narrative

Describe event or problem, corrected data: the initial report inadvertently did not report the information attained from the surgeon and the return product form.

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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 herzog
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key2881940
Report Number1644487-2012-03425
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/03/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/20/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2013
Device MODEL Number103
Device LOT Number3151
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/04/2012
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/25/2013
Was Device Evaluated By Manufacturer? No
Date Device Manufactured10/20/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 12/20/2012 Patient Sequence Number: 1