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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 02/18/2014
Event Type  Malfunction  
Event Description

It was reported that during an unrelated surgery the patient's generator was repositioned to the patient's right chest. The surgeon wanted to verify that the generator was working properly. The physician performed diagnostics which showed the generator was at neos. The surgeon confirmed that electrocautery was performed. The patient had not been prior consented for generator replacement; therefore, the generator could not be replaced at that time. It was later reported that the patient would be referred for generator replacement. Surgical intervention has not occurred to date.

 
Event Description

Additional information was received stating that the vns patient underwent generator replacement surgery on (b)(6) 2014 due to battery depletion. Electrocautery was used in a port-a-cath procedure on( b)(6) 2014 that caused the generator battery to drain. The explanted generator has been returned to the manufacturer where analysis is currently underway.

 
Event Description

Analysis of the returned generator was completed. Review of the data indicated that the pulsedisabled byte was set to a value that represents a vbat

 
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Brand NamePULSE GEN MODEL 103
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 Key3688612
Report Number1644487-2014-00715
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/18/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/19/2014
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 Number103
Device LOT Number202183
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/16/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/15/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/24/2012
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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