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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PUSLE GEN MODEL 103 GENERATORS

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CYBERONICS, INC. PUSLE GEN MODEL 103 GENERATORS Back to Search Results
Model Number 103
Event Date 04/27/2012
Event Type  Injury  
Event Description

Additional information was received that the infection was at the armpit and not where the generator was placed. There was no patient manipulation or trauma that contributed to the infection. Cultures were taken and results showed that they were pseudomonas species. They are planning to re-implant the patient but have not to date. Product analysis was completed on the generator. The device was returned due no malfunction suspected/identified and infection. 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

Additional information was received indicating the patient's culture results indicated gram negative bacteria. The bacteria originated from the armpit area. The patient had been put on cipro as intervention. The patient was indicated is now doing "fine" per the surgeon. Surgery to reimplant the patient with vns has occurred.

 
Event Description

It was initially reported that the patient had their generator explanted due to an infection. The patient was recently implanted and the infection was likely related to surgery. The generator was returned to the manufacturer for evaluation. Product analysis is planned but has not been completed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. Good faith attempts for more information have been unsuccessful to date.

 
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 NamePUSLE GEN MODEL 103
Type of DeviceGENERATORS
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 Key2613729
Report Number1644487-2012-01481
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/23/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/12/2012
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 Number3145
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/29/2012
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/11/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/18/2011
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: 06/12/2012 Patient Sequence Number: 1
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