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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102R GENERATOR Back to Search Results
Model Number 102R
Event Date 01/22/2007
Event Type  Injury  
Event Description

It was reported that the vns patient previously had his lead and generator replaced due to an unknown reason. Follow-up with the patient's previous surgeon found that the patient developed an infection following vns generator replacement due to end of service on (b)(6) 2006. The lead and generator were eventually explanted on (b)(6) 2007 after the wound was noted as "open and draining. " cultures were taken; however, the results were not available. The patient was later re-implanted on (b)(6) 2008. Attempts for the explanted generator product information have been unsuccessful to date.

 
Manufacturer Narrative

Initial report inadvertently did not indicate "30-day. ".

 
Event Description

Additional information was received as the previous implant card and operative report that indicate the explanted generator product information.

 
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Brand NamePULSE GEN MODEL 102R
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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2477735
Report Number1644487-2012-00584
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/03/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/05/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2008
Device MODEL Number102R
Device LOT Number015644
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/29/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/21/2006
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: 03/05/2012 Patient Sequence Number: 1
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