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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 06/20/2012
Event Type  Injury  
Manufacturer Narrative

 
Event Description

On (b)(6) 2012 a vns implanting surgeon's scheduler reported that the vns patient had an infection and is having surgery to move the generator from the left to the right side. The patient had recently undergone battery replacement on (b)(6) 2012 due to end of service. Surgery took place on (b)(6) 2012 and the generator was repositioned to the right side only; no replacement of the generator occurred. The patient's lead product information was requested from the implanting hospital but they stated they do not retain records over 10 years and since the leads were implanted in 2001 they do not have the records. Attempts for the patient's generator product information were also unsuccessful as the implanting hospital stated they would not give out this information without patient consent. Since patient consent is not available, the information cannot be obtained. (b)(4) attempts for further information from the surgeon were made but were unsuccessful.

 
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Brand NamePULSE GEN MODEL 102R
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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2680579
Report Number1644487-2012-01943
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation MEDICAL ASSISTANT
Type of Report Initial
Report Date 07/12/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/03/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number102R
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/12/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 08/03/2012 Patient Sequence Number: 1
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