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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 104 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 104 GENERATOR Back to Search Results
Model Number 104
Event Date 11/08/2014
Event Type  Injury  
Event Description

It was reported that the patient underwent explant due to an infection. It was later reported that the device was extruding. It was reported that there was no adverse event or trauma that may have caused the extrusion of the generator. No additional relevant information has been received to date.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

 
Event Description

The patient under went a full re-implant after healing from infection on (b)(6) 2015. The patient's generator was reimplanted in the right chest with a new lead still present on the left nerve. At this time it appears that at the time of explant in (b)(6) 2014 for the known infection, the lead was likely clipped as there is no indication of the lead being salvaged for future use. Additionally, it would be likely that the lead was partially removed at this time as the report doesn't indicate use of an accessory kit.

 
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Brand NamePULSE GEN MODEL 104
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 Key4318047
Report Number1644487-2014-03262
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/10/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/10/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2015
Device MODEL Number104
Device LOT Number202458
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/12/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/25/2013
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: 12/10/2014 Patient Sequence Number: 1
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