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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 05/01/2010
Event Type  Injury  
Event Description

It was initially reported by the surgeon that the pt picked at the generator incision site and the wound dehisced. Cultures showed positive for staphylococcus. Pt was admitted to the hosp and the device was removed. Design history review was done and it was confirmed that the device was sterile at the time of dispatch from the hosp.

 
Manufacturer Narrative

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

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1745787
Report Number1644487-2010-01559
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/03/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/01/2010
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 Number102
Device LOT Number2214
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received06/03/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2008
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: 07/01/2010 Patient Sequence Number: 1
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