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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Event Date 08/10/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that the patient was scheduled for surgery to reposition, the vns generator in a different location. The reason for the repositioning surgery was not immediately known. Further follow-up found that the patient presented with an infection after a recent generator replacement surgery. Review of the manufacturing records confirmed that the generator was sterilized and passed quality control inspection prior to distribution. The generator was repositioned during a surgery on (b)(6) 2016 where it was kept in the left chest however it was moved to a new location. After being repositioned, a diagnostic test found an impedance value the within acceptable range. No additional relevant information has been received to date.

 
Event Description

It was reported that following the repositioning surgery the patient developed a dehiscence wound which required additionally surgery to close the wound. At the time of the report the dehiscence wound did not appear to be related to the original infection therefore the dehiscence wound event was reported in mfg report #1644487-2017-03189. It was later reported that fluid then began to build in the pocket and the patient was again referred to surgery to drain the pocket and explant the generator. During the surgery fluid was observed inside the lead. The surgeon was concerned that the fluid leaks in the lead could have been a contributing factor for the infection issues that were previously reported in this report and in mfg report #1644487-2017-03189. The fluid leaks in the lead and dehiscence wound events are being reported in mfg report #1644487-2017-03189. While this report will only capture the initial infection that occurred after the generator replacement surgery.

 
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Brand NamePULSE GEN MODEL 106
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key6113549
Report Number1644487-2016-02673
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/17/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/18/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2017
Device MODEL Number106
Device LOT Number4550
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/27/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/07/2015
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: 11/18/2016 Patient Sequence Number: 1
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