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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 09/02/2013
Event Type  Injury  
Event Description

It was reported that the patient underwent explant due to an infection at the chest generator site. It was reported that the patient was seen outpatient to have the device programmed on and that is when the infection was found. It was reported that the hospital decided to explant on the same date. It was reported that the hospital would not release the explanted devices to manufacturer. It was reported that the physician has not intent on implanting another vns system. It was reported that the infection was not related to vns. There was not patient manipulation or trauma. No culture were taken. It was reported that the wound was open because of the improper implant placement of the generator, which caused the infection.

 
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3487391
Report Number1644487-2013-03605
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 10/29/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/25/2013
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 Number102
Device LOT Number202460
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/29/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/26/2013
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: 11/25/2013 Patient Sequence Number: 1
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