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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 01/31/2010
Event Type  Malfunction  
Event Description

It was reported that the pt was seen for a follow up appointment due to sudden neck pain, which the pt felt was related to the vns device. In addition, the pt had been sick over the previous weekend with vomiting, and the neck pain worsened. The pt had secured the magnet over the generator site to temporarily disable stimulation until the appointment. At the follow up appointment, a system diagnostic test was performed which revealed high lead impedance. The pt subsequently had surgery where only the generator was replaced. Further follow up with the surgeon revealed that the high lead impedance resolved when a new generator was connected to the existing lead. Good faith attempts to obtain additional information are underway. The explanted generator has been returned to manufacturer where analysis is underway.

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1634497
Report Number1644487-2010-00568
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/08/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/10/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2010
Device MODEL Number102
Device LOT Number200843
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer03/08/2010
Is The Reporter A Health Professional? Yes
Date Manufacturer Received02/08/2010
Was Device Evaluated By Manufacturer? No
Date Device Manufactured06/01/2008
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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