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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 103 GENERATOR

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CYBERONICS INC PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 09/05/2013
Event Type  Injury  
Event Description

It was reported that the patient was involved in a fight which caused the chest incision to open up. The physician indicated that he believes the generator site is infected. Culture were performed, but showed no growth; however, the physician reported that the patient had already been on antibiotics at the time the cultures were performed. The physician indicated that explant is planned. Surgery is likely, but has not occurred to date.

 
Event Description

Additional information received revealed that the patient had the device explanted on (b)(6) 2013. No signs of infection were found during a follow-up appointment post device removal. The patient will have another appointment next year to determine what the next steps will be.

 
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 103
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 Key3406168
Report Number1644487-2013-03143
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/12/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/11/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2015
Device MODEL Number103
Device LOT Number202443
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/12/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/13/2013
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: 10/11/2013 Patient Sequence Number: 1
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