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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 02/23/2012
Event Type  Injury  
Event Description

All attempts to the reporter for additional information and if explant of the vns occurred have been unsuccessful to date.

 
Event Description

Reporter indicated a patient was to have the vns generator and possibly the lead explanted and not replaced due to patient reports of constant pain in the left upper chest and neck. The surgery was to have taken place on (b)(6) 2012, but this has not been confirmed. Attempts for further information are in progress.

 
Event Description

Product analysis was completed on the returned vns generator. No anomalies were noted, and the generator performed per specifications.

 
Event Description

Reporter indicated the patient had the vns generator explanted on (b)(6) 2012, but the vns lead was left in the patient. The vns generator was explanted at the request of the patient. The generator has been returned and is pending product analysis.

 
Manufacturer Narrative

Operator of device, corrected data: the incorrect operator of the device was inadvertently reported as the health professional on the initial mdr report. The correct operator of the device is the patient.

 
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Brand NamePULSE GEN MODEL 102
Type of DevicePULSE GEN MODEL 102
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 grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2498646
Report Number1644487-2012-00768
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 02/23/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/21/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/30/2008
Device MODEL Number102
Device LOT Number016488
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/11/2012
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/12/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/08/2007
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: 03/21/2012 Patient Sequence Number: 1
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