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U.S. Department of Health and Human Services

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

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CYBERONICS INC PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 07/25/2012
Event Type  Injury  
Event Description

On (b)(6) 2012, a vns surgeon's coordinator reported that the vns patient was scheduled for an incision and drainage surgery on the chest wound on (b)(6) 2012 and her generator will be explanted at the same time. The patient's generator pocket/incision was infected/dehiscence. The patient had recently undergone battery replacement surgery on (b)(6) 2012. It was later discovered that the surgery was postponed until (b)(6) 2012. The surgeon plans on explanting the generator and then repositioning the lead, leaving it fully intact. The infection will be healed before the patient is re-implanted with a new generator. The device was explanted as planned. The surgeon believes that the patient picked at the sutures at the generator incision in the patient's left chest which caused the infection/dehiscence. Cultures were taken but the results were not provided. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

 
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 102
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 herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2706616
Report Number1644487-2012-02062
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/25/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/20/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2013
Device MODEL Number102
Device LOT Number201980
Was Device Available For Evaluation? No
Event Location Other
Date Manufacturer Received07/25/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/05/2012
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: 08/20/2012 Patient Sequence Number: 1
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