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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 01/28/2015
Event Type  Malfunction  
Event Description

It was reported that during generator replacement surgery on (b)(6) 2015, the vns patient¿s replacement device was hit by electrocautery which resulted in a low battery condition of the device. The surgeon elected the implant the device. Follow-up revealed that the patient¿s device was functioning normally.

 
Manufacturer Narrative

 
Manufacturer Narrative

(b)(4). The initial mdr inadvertently did not include the suspect device udi. This report is being submitted to correct this data.

 
Event Description

It was reported that the patient's device was at eos - yes due to suspected electrocautery from the procedure in 2015. The generator was replaced however the explanted generator has not been received by the manufacturer to date.

 
Event Description

Additional information was received that the explanting facility would not return the explanted generator so product return is not expected.

 
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Brand NamePULSE GEN MODEL 103
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 Key4536309
Report Number1644487-2015-03943
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 12/25/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/23/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2016
Device MODEL Number103
Device LOT Number3999
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/30/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/28/2014
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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