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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 09/28/2010
Event Type  Malfunction  
Event Description

It was initially reported by a nurse that a vns pt experienced "complications" due to unk reason. The pt just had her vns re-implanted on (b)(6) 2010 due to high lead impedance. During f/u with the surgeon's office, it was found that there had been "complications" during the replacement surgery including fibrosis present around the lead body and bleeding that occurred when the surgeon accidently nicked the jugular vein (addressed in mfr report# 1644487-2010-02173). The surgeon's office stated that they did not have any product info regarding the lead. The pt had stayed overnight in the hosp for monitoring but no actions were needed. Moreover, additional info from a company rep indicated there was still high lead impedances after replacement surgery which took place on (b)(6) 2010. The surgeon and nurse indicated that everything was fine in the operating room and system test was ok. The treating nurse checked the pt when she came in for a f/u and said there were still high impedance (>10kohms/eos=10 yrs). The pt was referred for a pin re-insertion and possible lead replacement with a different surgeon. Info from the initial surgeon through a company rep indicated that there was no report of pt trauma or manipulation. Additional info was received from a company rep who indicated the pt underwent pin re-insertion surgery with a different surgeon. There was no high impedance noted after the re-insertion and after using another pulse generator. System diagnostics after generator replaced were ok with dcdc 2 and eos no.

 
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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 Key1898616
Report Number1644487-2010-02483
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 10/12/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/04/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2011
Device MODEL Number103
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received10/12/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2010
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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