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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 103

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CYBERONICS INC PULSE GEN MODEL 103 Back to Search Results
Model Number 103
Event Date 03/01/2011
Event Type  Injury  
Event Description

Reporter indicated a patient vns generator repositioning surgery on (b)(6) 2011 due to pain at the generator site. The pain was due to sub-pectoral placement of the vns. The generator was repositioned under the skin and the pain resolved. No devices were explanted, and the generator was reported to be performing as intended.

 
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Brand NamePULSE GEN MODEL 103
Type of DevicePULSE GEN MODEL 103
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 grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2327033
Report Number1644487-2011-02671
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 10/12/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/07/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2012
Device MODEL Number103
Device LOT Number201595
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/12/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/04/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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