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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Event Date 06/01/2013
Event Type  Injury  
Event Description

It was initially reported that the patient had a infection at the generator site. The patient apparently had the infection for weeks. The patient was recently implanted (b)(6) 2013. The patient was having surgery to either revise or remove the vns. It has not been confirmed which was done. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution good faith attempts for additional information have been unsuccessful to date.

 
Event Description

On (b)(6) 2013, it was reported that the patient did not have an infection. Cultures were taken three times and were negative and inclusive. The patient had wound dehiscence, and the skin over the generator was very thin. There was barely any tissue left when the patient was seen (b)(6) 2013. The wound opened, exposing the generator as they were going in for surgery (in or right before or). The patient did not have the generator replaced: the generator was implanted deeper. Surgery was on (b)(6) 2013. The cause was unknown, but it was likely related to the patient¿s physiology and response. No known trauma or change that would have caused the issue. The patient had not been seen since surgery.

 
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 NamePULSE GEN MODEL 105
Type of DeviceGENERATOR
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3223298
Report Number1644487-2013-02091
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/21/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/12/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/30/2014
Device MODEL Number105
Device LOT Number202301
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/31/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/06/2012
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: 07/12/2013 Patient Sequence Number: 1
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