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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Event Date 03/11/2014
Event Type  Malfunction  
Event Description

It was reported that the explanting facility will not returned explanted devices without patient consent; therefore, device analysis cannot not be performed.

 
Event Description

An implant card was received indicating that the vns patient¿s generator was replaced due to neos = yes. Additional programming and diagnostic history was received showing normal diagnostic results through (b)(4) 2013.

 
Event Description

Follow-up with the surgeon was performed, and he reported that electrocautery was not used during the repositioning surgery on (b)(6) 2013 or during any other procedures between implant in (b)(6) 2014. It is known and addressed in device labeling that exposure of electrocautery or rf device can damage the generator and cause premature depletion.

 
Manufacturer Narrative

Device manufacturing records and available programming and diagnostic history were reviewed. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.

 
Event Description

It was reported that the vns patient's generator showed ifi - yes. The physician reported that the generator must be faulty as it was implanted in (b)(6) 2013. It was reported that the patient underwent another surgery in (b)(6) 2013. It was reported that device diagnostics were within normal limits. The patient was referred for generator replacement. The patient underwent generator replacement on (b)(6) 2014. The generator is expected to be returned for analysis, but has not been received to date. Attempts to obtain additional relevant information have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 105
Type of DeviceGENERATOR
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3734824
Report Number1644487-2014-00940
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 03/11/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/08/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2014
Device MODEL Number105
Device LOT Number3439
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/04/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/26/2012
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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