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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 102R GENERATOR

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CYBERONICS INC PULSE GEN MODEL 102R GENERATOR Back to Search Results
Model Number 102R
Event Date 09/15/2011
Event Type  Injury  
Event Description

It was reported that the vns patient would be having surgery to move the patient's generator to the right side of the chest as the patient initially had an infection due to a spine surgery unrelated to vns that spread to the left chest. It was initially unknown if the generator had been infected. Additional information was later received confirming that surgery had occurred. On (b)(6) 2011, the patient had presented with an exposed device and infected wound post the spine surgery. The patient's parents indicated that the device site became inflamed one week following the spine surgery. During the surgery to replace the generator, the generator was removed from the pocket and treated with betadine. It was then re-implanted in the right chest. Cultures taken during surgery indicated antibiotic resistant staphylococcus. The patient was last seen on (b)(6) 2012 during which it was observed that the left wound was still open and the right site was intact. No further interventions have been indicated at this time.

 
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 102R
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS INC
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2445195
Report Number1644487-2012-00341
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/10/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/09/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2012
Device MODEL Number102R
Device LOT Number201567
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/10/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/02/2010
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: 02/09/2012 Patient Sequence Number: 1
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