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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 11/09/2009
Event Type  Malfunction  
Event Description

It was reported that a vns pt's generator was explanted due to pain at the generator site. The explanted generator was returned to the mfr and underwent product analysis. Product analysis performed on the returned generator revealed an end of service warning message which was associated with the output being disabled by the pulse generator. Once the output was re-enabled, the following was observed: electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator. The reported eos condition was not duplicated during the pa analysis. Capa (b)(4) further investigated the eos condition of the generator and revealed the root cause of the eos warning messages as being an asic latch-up condition resulting from the pulse generator receiving an electrical transient during implant surgery. The electrical transient is the result of electromagnetic induction (emi) or electrostatic discharge (esd). This emi and/or esd causing the asic latch-up can be attributed to: the use of monopolar electrosurgery in direct contact with the pulse generator; monopolar electrosurgery in close vicinity to the pulse generator; or a major electrostatic discharge. The pain event is further reported in mfr report # 1644487-2009-02675 along with the product analysis of the generator.

 
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Brand NamePULSE GEN MODEL 103
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1614971
Report Number1644487-2010-00405
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/16/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/19/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2009
Device MODEL Number103
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer11/30/2009
Is The Reporter A Health Professional? Yes
Date Manufacturer Received02/16/2010
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/01/2008
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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