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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 06/03/2012
Event Type  Malfunction  
Event Description

A vns consultant was at a patient's clinic visit and it was noted that the patient had high lead impedance. : lead impedance high, output current = low, and impedance value = over 10000ohms. There was no trauma reported. The patient could not feel the stimulation, even after they tried to increase the settings. The patient usually had a noticable change in voice with stimulation, but that was no longer noticable. It was reported that a week ago the patient had turned her head to the right, and had felt like the stimulation was stronger. This was the only occurrence of "stronger stimulation". The patient went to surgery. Their impedance was high when a system diagnostic test was done before surgery. The connector pin was not inserted all the way. The connector pin was taken out and put back in and their high impedance resolved. After the pin was re inserted three system diagnostics tests where run with all ok.

 
Manufacturer Narrative

The connector pin was not fully inserted into the header of the generator confirmed in surgery.

 
Manufacturer Narrative

Date of event corrected data: updated to reflect actual date of event.

 
Event Description

Programming history was received for review and a change in impedance was noted on (b)(6) 2012 to over 10,000 ohms. Their generator was disabled on 7/19 prior to surgery. No patient fall was reported prior to their high impedance being attained. X-rays were not sent to the manufacturer for review.

 
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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 770
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 Key2685054
Report Number1644487-2012-01958
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/19/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/07/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2013
Device MODEL Number103
Device LOT Number201906
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Distributor Facility Aware Date07/19/2012
Event Location Other
Date Manufacturer Received10/19/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/13/2011
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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