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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Event Date 10/01/2012
Event Type  Injury  
Event Description

An analysis was performed on the returned lead portion. Note that the lead assembly (body) including a section of the connector boot containing the serial number tag and the electrode section was not returned; therefore it was not possible to verify the model and serial number during this analysis and 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 setscrew marks found on the marked connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities 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 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. The generator was returned: results of diagnostic testing indicated the device was operating properly and communicated properly. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator.

 
Event Description

On (b)(6) 2012, it was reported that a physician had concern that t vns patient may be having an allergic reaction to the device. In the last 2 months, swelling and fluid collections were observed in the neck near where the leads are implanted. Cultures were taken and came back negative, so it was not believed to be an infection. The patient underwent lead and generator explant on (b)(6) 2012. The patient's neck wound was noted to be red a few weeks prior. At that time, it was cleaned; however, since that time, the wound had opened up. Pus was located at the electrode site during explant surgery. Cultures were taken but the results were not provided. The explanted generator and lead were returned on (b)(6) 2012 and are currently undergoing product analysis. Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

 
Manufacturer Narrative

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

 
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Brand NameLEAD MODEL 304
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2915389
Report Number1644487-2013-00147
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/20/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/15/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2015
Device MODEL Number304-20
Device LOT Number3159
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/26/2012
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/24/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/27/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/15/2013 Patient Sequence Number: 1
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