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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102R Back to Search Results
Model Number 102R
Event Date 09/01/2009
Event Type  Injury  
Event Description

It was indicated by the surgeon that pt had an explant surgery due to "wound dehiscence-infection. " explanted products were discarded, so will not be returned. Pt was not re-implanted that time. Device sterility records were checked and it was confirmed that the device was sterile at the time of dispatch from the manufacture. Follow up with the surgeon's nurse revealed that infection was related to the implant surgery. Cultures were taken, but she does not remember what they were. No pt manipulation or trauma was reported. Pt's body did not take the surgery very well; therefore, developed an infection at the generator site.

 
Manufacturer Narrative

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

 
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Brand NamePULSE GEN MODEL 102R
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1527014
Report Number1644487-2009-02520
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 10/12/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/11/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2010
Device MODEL Number102R
Device LOT Number200956
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received10/12/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/01/2008
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: 11/11/2009 Patient Sequence Number: 1
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